Cabotegravir

Associated long-acting platforms

Aqueous drug particle suspension

Administration route

Oral, Intramuscular, Subcutaneous

Therapeutic area(s)

Use case(s)

Use of drug

Dosage

Drug information

Delivery device(s)

No delivery device

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

POLAR

Identifier

NCT03639311

Link

https://clinicaltrials.gov/study/NCT03639311

Phase

Phase II

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Assess the antiviral activity and safety of CAB LA plus RPV LA, administered Q2M, in approximately 100 adult HIV-1 infected, antiretroviral therapy (ART) experienced participants.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2018-09-24 00:00:00

Anticipated Date of Last Follow-up
2024-05-13 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2019-12-11 00:00:00

Actual Completion Date
2023-01-30 00:00:00

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Participants will rollover from the NCT01641809 (LATTE) study, who have completed minimum duration of Week 312 and with demonstrated HIV-1 ribonucleic acid (RNA) suppression (less than [<]50 copies (c) per milliliter [mL]), while receiving a two-drug regimen consisting of once-daily oral CAB at 30 milligram (mg) plus RPV at 25 mg. The participants will be offered the option to switch to the LA, intramuscular injections of CAB LA plus RPV LA, Q2M or the oral fixed dose combination (FDC) of dolutegravir (DTG) plus RPV, for the continued maintenance of HIV-1 RNA suppression, known as the Maintenance Phase (From Day 1 to Commercial Approval).

Health status

Study type

Interventional (clinical trial)

Enrollment

97

Allocation

Non-randomized

Intervention model

Parallel Assignment

Intervention model description

This is an Intervention Model, with parallel assignment, where the primary purpose of the study is, treatment, with 2 arms and no masking.

Masking

Open label

Masking description

This is an open-label study, thus no masking.

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CUSTOMIZE

Identifier

NCT04001803

Link

https://clinicaltrials.gov/study/NCT04001803

Phase

Phase III

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Identify and Evaluate Strategies for Successful Implementation of the Cabotegravir + Rilpivirine Long-acting Injectable Regimen in the US.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-07-08 00:00:00

Anticipated Date of Last Follow-up
2023-03-16 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2020-10-05 00:00:00

Actual Completion Date
2022-03-18 00:00:00

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: - Aged 18 years or older at the time of signing the informed consent. - HIV-1 infected and must be on an active highly active antiretroviral therapy (HAART) (2 or 3 drug) regimen for at least 6 months prior to Screening. - Be able to understand and comply with protocol requirements, instructions, and restrictions. - Understand the long-term commitment to the study and be likely to complete the study as planned. - Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications.

Health status

Study type

Interventional (clinical trial)

Enrollment

115

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CR109089

Identifier

NCT05112939

Link

https://clinicaltrials.gov/study/NCT05112939

Phase

Phase I

Status

Completed

Sponsor

Janssen Research & Development, LLC

More details

Not provided

Purpose

Characterize the single dose pharmacokinetics and evaluate the safety and tolerability of subcutaneous administration of RPV LA in combination with CAB LA in different conditions in healthy adults.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-11-16 00:00:00

Anticipated Date of Last Follow-up
2025-02-27 00:00:00

Estimated Primary Completion Date
2024-05-23 00:00:00

Estimated Completion Date
2024-05-23 00:00:00

Actual Primary Completion Date
2024-05-23 00:00:00

Actual Completion Date
2024-05-23 00:00:00

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Participant must be healthy on the basis of physical examination, clinical laboratory tests, medical history, vital signs, and 12-lead electrocardiogram (ECG).

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

126

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Single blind masking

Masking description

Single (Participant)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

ATLAS-2M

Identifier

NCT03299049

Link

https://clinicaltrials.gov/study/NCT03299049

Phase

Phase III

Status

Active, not recruiting

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine in HIV-1-infected Adults Who Are Virologically Suppressed.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2017-10-27 00:00:00

Anticipated Date of Last Follow-up
2024-12-10 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-12-31 00:00:00

Actual Primary Completion Date
2019-06-06 00:00:00

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: - Subjects who will be able to understand and comply with protocol requirements, instructions, and restrictions. - Understand the long term commitment to the study and be likely to complete the study as planned. - Be considered as an appropriate candidate for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.). - Aged 18 years or older (or >=19 where required by local regulatory agencies), at the time of signing the informed consent.

Health status

Study type

Interventional (clinical trial)

Enrollment

1049

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Two groups of subjects will be randomized to receive CAB LA + RPV LA Q4W, or CAB LA + RPV LA Q8W regimen.

Masking

Open label

Masking description

This will be an open-label study and therefore no blinding is required.

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

SOLAR

Identifier

NCT04542070

Link

https://clinicaltrials.gov/study/NCT04542070

Phase

Phase III

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-11-09 00:00:00

Anticipated Date of Last Follow-up
2024-06-03 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2022-07-13 00:00:00

Actual Completion Date
2023-04-17 00:00:00

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: - Participants aged 18 years or older (or >=19 where required by local regulatory agencies), at the time of signing the informed consent. - A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at screen and a negative urine hCG test at Randomization). - Must be on the uninterrupted current regimen of BIK for at least 6 months prior to Screening with an undetectable HIV-1 viral load for at least 6 months prior to Screening. BIK must be the participant's first or second regimen. - Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Health status

Study type

Interventional (clinical trial)

Enrollment

687

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

ATLAS

Identifier

NCT02951052

Link

https://clinicaltrials.gov/study/NCT02951052

Phase

Phase III

Status

Active, not recruiting

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Establish if HIV-1 infected adult subjects with current viral suppression on a regimen with 2 NRTIs plus a third agent, remain suppressed upon switching to a 2 drug intramuscular regime of CAB/RPV-LA.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2016-10-28 00:00:00

Anticipated Date of Last Follow-up
2025-01-09 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-12-31 00:00:00

Actual Primary Completion Date
2018-05-29 00:00:00

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Must be on uninterrupted current ARV regimen (either the initial or second ARV regimen) for at least 6 months prior to Screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for treatment failure (HIV-1 RNA ≥400 c/mL).

Health status

Study type

Interventional (clinical trial)

Enrollment

618

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

FLAIR

Identifier

NCT02938520

Link

https://clinicaltrials.gov/study/NCT02938520

Phase

Phase III

Status

Active, not recruiting

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Establish if HIV-1 infected adult participants whose virus is virologically suppressed on an INI STR will remain suppressed after switching to a two drug LA regimen of CAB and RPV.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2016-10-27 00:00:00

Anticipated Date of Last Follow-up
2025-03-04 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-12-31 00:00:00

Actual Primary Completion Date
2018-08-30 00:00:00

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Antiretroviral-naive (<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection). Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary.

Health status

Study type

Interventional (clinical trial)

Enrollment

631

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CARISEL

Identifier

NCT04399551

Link

https://clinicaltrials.gov/study/NCT04399551

Phase

Phase III

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-09-28 00:00:00

Anticipated Date of Last Follow-up
2024-04-04 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2022-03-07 00:00:00

Actual Completion Date
2023-03-13 00:00:00

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

HIV-1 infected and must be suppressed on a guideline recommended active Highly active antiretroviral therapy (HAART) regimen for at least 6 months prior to screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must not have been done for virologic failure (on treatment HIV-1 RNA more than or equal to [>=]200 c/mL).

Health status

Study type

Interventional (clinical trial)

Enrollment

437

Allocation

Non-randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

This is an open-label study hence no blinding is required.

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

LATA

Identifier

NCT05154747

Link

https://clinicaltrials.gov/study/NCT05154747

Phase

Phase III

Status

Active, not recruiting

Sponsor

University College, London

More details

Not provided

Purpose

Comparing the efficacy of long-acting injectable CAB+RPV administered every two months in comparison to daily oral HIV medications in young people.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-06-22 00:00:00

Anticipated Date of Last Follow-up
2024-04-26 00:00:00

Estimated Primary Completion Date
2025-03-01 00:00:00

Estimated Completion Date
2026-03-01 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Adolescents
• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Study participants are individuals with HIV-1 infection aged 12-19 years in Sub-Saharan Africa. Participants with known HIV-2 infection are excluded.

Health status

Study type

Interventional (clinical trial)

Enrollment

476

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

IMPALA

Identifier

NCT05546242

Link

https://clinicaltrials.gov/study/NCT05546242

Phase

Phase III

Status

Active, not recruiting

Sponsor

MRC/UVRI and LSHTM Uganda Research Unit

More details

Not provided

Purpose

Evaluating the Effectiveness of Switching to Two-monthly Long-acting Injectable CAB and RPV From First-line Oral Antiretroviral Therapy in HIV-1 Positive Virologically Suppressed Adults in SSA.

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-12-08 00:00:00

Anticipated Date of Last Follow-up
2024-09-25 00:00:00

Estimated Primary Completion Date
2025-04-01 00:00:00

Estimated Completion Date
2026-03-01 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Participants must have a history of sub-optimal ART adherence or engagement in care based on one or more of the following criteria: 1. Documented detectable HIV-1 VL (>1000 c/mL) on all-oral ART (EFV/NVP or DTG-based) in the prior 2 years despite being ART-experienced for ≥3 months. 2. History of being lost to follow-up from care (>4 weeks elapsed since a missed scheduled clinic appointment or refill in the prior 2 years). 3. Failed to link to HIV care despite ≥3 months elapsed since HIV diagnosis.

Health status

Study type

Interventional (clinical trial)

Enrollment

540

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Parallel open-label phase 3b study. Participants will be randomised to continuing current therapy or switching to injectable therapy.

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

LATITUDE

Identifier

NCT03635788

Link

https://clinicaltrials.gov/study/NCT03635788

Phase

Phase III

Status

Active, not recruiting

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

More details

Not provided

Purpose

Compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-03-28 00:00:00

Anticipated Date of Last Follow-up
2025-04-22 00:00:00

Estimated Primary Completion Date
2024-09-30 00:00:00

Estimated Completion Date
2026-08-30 00:00:00

Actual Primary Completion Date
2024-02-12 00:00:00

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Evidence of non-adherence to ART according to at least one of the following criteria: 1. Poor virologic response within 18 months prior to study entry (defined as less than 1 log10 decrease in HIV-1 RNA or HIV-1 RNA greater than 200 copies/mL at two time points at least 4 weeks apart) in individuals who have been prescribed ART for at least 6 consecutive months. 2. Lost to clinical follow-up within 18 months prior to study entry with ART non-adherence for greater than or equal to 6 consecutive months.

Health status

Study type

Interventional (clinical trial)

Enrollment

456

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

LATTE-2

Identifier

NCT02120352

Link

https://clinicaltrials.gov/study/NCT02120352

Phase

Phase II

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate the antiviral activity, tolerability, and safety of IM dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 plus ABC/3TC given orally once daily, in ARV naïve HIV-1 patients.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2014-04-28 00:00:00

Anticipated Date of Last Follow-up
2024-06-11 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2015-08-13 00:00:00

Actual Completion Date
2023-04-20 00:00:00

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Participants must be ART-naïve defined as having no more than 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection.

Health status

Study type

Interventional (clinical trial)

Enrollment

309

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

NCT04371380

Identifier

NCT04371380

Link

https://clinicaltrials.gov/study/NCT04371380

Phase

Phase I

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate pharmacokinetics, tolerability, and safety of Cabotegravir long acting plus Rilpivirine long acting administered concomitantly as two separate IM injections in the Vastus Lateralis muscles.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-09-16 00:00:00

Anticipated Date of Last Follow-up
2023-11-03 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2021-12-26 00:00:00

Actual Completion Date
2021-12-26 00:00:00

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Participants aged 18 to 50 who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

Health status

Study type

Interventional (clinical trial)

Enrollment

15

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Eligible participants will receive orally, tablets of cabotegravir plus rilpivirine for 28 days. There will be 10 to 14 days wash out period followed by an IM injection of cabotegravir long-acting plus rilpivirine long-acting.

Masking

Open label

Masking description

This is an open label study.

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

LAI115428

Identifier

NCT01593046

Link

https://clinicaltrials.gov/study/NCT01593046

Phase

Phase I

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2012-05-01 00:00:00

Anticipated Date of Last Follow-up
2014-02-06 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2013-11-01 00:00:00

Actual Completion Date
2013-11-01 00:00:00

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: - AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - Healthy as determined by a responsible and experienced physician. - Male or female between 18 and 64 years of age inclusive, at the time of signing the informed consent. - Body weight greater than or equal to 50 kg for men and greater than or equal to 45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg/m2 (inclusive). - All Study subjects should be counseled on the practice of safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide).

Health status

Study type

Interventional (clinical trial)

Enrollment

43

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Unspecified

Key resources

CAPRI

Identifier

NCT05601128

Link

https://clinicaltrials.gov/study/NCT05601128

Phase

Phase III

Status

Completed

Sponsor

Allegheny Singer Research Institute

More details

Not provided

Purpose

Evaluate the efficacy and safety of CABENUVA (Long-acting Cabotegravir Plus Long-acting Rilpivirine) in patients with HIV infection and severe renal impairment.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-01-01 00:00:00

Anticipated Date of Last Follow-up
2025-02-06 00:00:00

Estimated Primary Completion Date
2025-04-01 00:00:00

Estimated Completion Date
2025-12-31 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Participants are positive for HIV infection and severe renal impairment with or without hemodialysis.

Health status

Study type

Interventional (clinical trial)

Enrollment

12

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

MOCHA

Identifier

NCT03497676

Link

https://clinicaltrials.gov/study/NCT03497676

Phase

Phase I/II

Status

Active, not recruiting

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

More details

Not provided

Purpose

Evaluate the safety, acceptability, tolerability, and pharmacokinetics of oral and long-acting injectable CAB and RPV in virologically suppressed HIV-infected children and adolescents.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-04-03 00:00:00

Anticipated Date of Last Follow-up
2024-09-03 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-06-17 00:00:00

Actual Primary Completion Date
2023-02-18 00:00:00

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Adolescents

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Not provided

Health status

Study type

Interventional (clinical trial)

Enrollment

168

Allocation

Non-randomized

Intervention model

Sequential assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

VOLITION

Identifier

NCT05917509

Link

https://clinicaltrials.gov/study/NCT05917509

Phase

Phase III

Status

Active, not recruiting

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate the efficacy, safety, implementation effectiveness, and patient-reported outcomes of once-daily oral DTG/3TC followed by an optional participant-determined switch to CAB/RPV-LA.

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-07-28 00:00:00

Anticipated Date of Last Follow-up
2025-05-13 00:00:00

Estimated Primary Completion Date
2025-09-03 00:00:00

Estimated Completion Date
2026-09-03 00:00:00

Actual Primary Completion Date
2026-01-30 00:00:00

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Antiretroviral-naïve participants (defined as no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) prior to enrolment with plasma HIV-1 RNA ≥1,000 c/mL at screening. Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.

Health status

Study type

Interventional (clinical trial)

Enrollment

171

Allocation

Non-randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

ALADDIN

Identifier

NCT06468995

Link

https://clinicaltrials.gov/study/NCT06468995

Phase

Phase III

Status

Recruiting

Sponsor

IRCCS San Raffaele

More details

This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study aimed at comparing hospital-based and home-based administration of CAB LA + RPV LA treatment for HIV-1-infected patients. Study participants receiving IM CAB + RPV will complete various questionnaires and scales, including FIM, AIM, IAM, EQ-5D-5L, HAT-QoL, and HIVTSQ, throughout the study. HCPs will also complete FIM, AIM, IAM, and a Likert scale.

Purpose

Antiviral Long Acting Drugs Landing in People Living With HIV

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-09-01 00:00:00

Actual Start Date
2024-12-02 00:00:00

Anticipated Date of Last Follow-up
2024-12-04 00:00:00

Estimated Primary Completion Date
2026-03-01 00:00:00

Estimated Completion Date
2026-11-01 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: - People living with HIV-1 infection that could, according to clinical practice, switch current ART to IM CAB + RPV; - Aged 18 years or older at the time of signing the informed consent. - People willing to switch to long-acting therapy - On a stable (≥6 months) antiretroviral regimen and virologically suppressed (HIV-1 RNA \<50 copies/ml): - Documented evidence of plasma HIV-1 RNA measurements \<50 c/mL in the 6 months prior to Screening. - Plasma HIV-1 RNA \<50 c/mL at Screening. - Ability to understand informed consent form and other relevant regulatory documents.

Health status

Study type

Interventional (clinical trial)

Enrollment

120

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CROWN

Identifier

NCT06694805

Link

https://clinicaltrials.gov/study/NCT06694805

Phase

Phase III

Status

Recruiting

Sponsor

ViiV Healthcare

More details

This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.

Purpose

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

Interventions

Not provided

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-12-02 00:00:00

Anticipated Date of Last Follow-up
2025-02-18 00:00:00

Estimated Primary Completion Date
2026-05-13 00:00:00

Estimated Completion Date
2027-12-08 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Age 1. Aged \>=12 years and \>=35 kg (at the time of obtaining informed consent). * Type of Participant and Disease Characteristics 2.HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL. 3.Plasma HIV-1 RNA \>1 000 c/mL and greater than (\<) 100 000 c/mL at Screening. 4.Evidence of insufficient virologic response to participant's current oral ART regimen within 18 months prior to study entry according to at least 1 of the following criteria: i.\<1 log10 decrease in HIV-1 RNA or HIV-1 RNA \>200 c/

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

332

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Not provided

Key resources

PANNA

Identifier

NCT00825929

Link

https://clinicaltrials.gov/study/NCT00825929

Phase

Marketed

Status

Recruiting

Sponsor

Radboud University Medical Center

More details

Due to the potential for pregnancy-induced changes in the pharmacokinetics of medication, one cannot assume that the currently licensed doses of the medication to be tested under this protocol lead to adequate exposure in an HIV-infected pregnant woman. For the agents under study no or limited pharmacokinetic data during pregnancy are available. As the changes in pharmacokinetics during pregnancy are most prominent in the third trimester a pharmacokinetic curve will be recorded in the third trimester after attaining steady state.

Purpose

Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2009-02-01 00:00:00

Anticipated Date of Last Follow-up
2025-01-10 00:00:00

Estimated Primary Completion Date
2026-12-01 00:00:00

Estimated Completion Date
2026-12-01 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Female

Accepts pregnant individuals
Yes

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

HIV-infected pregnant women using at least one of the following antiretroverial agents: Etravirine, Intelence, TMC125; Emtricitabine, Emtriva or FTC; Tenofovir, Viread, TDF; Atazanavir, Reyataz; Fosamprenavir, Telzir, FPV; Darunavir, Prezista, TMC114; Tipranavir, Aptivus, TPV; Indinavir, Crixivan; abacavir; raltegravir, Isentress; Enfuvirtide, Fuzeon; Maraviroc, Celsentri; dolutegravir; elvitegravir/cobicistat; rilpivirine, TAF, darunavir/cobicistat; doravirine; bictegravir; cabotegravir/rilpivirine LA

Health status

Study type

Observational studies (incl. patient registries)

Enrollment

176

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

ILANA

Identifier

NCT05294159

Link

https://clinicaltrials.gov/study/NCT05294159

Phase

Marketed

Status

Completed

Sponsor

Queen Mary University of London

More details

This is a 12-month, dual arm, phase 4, open-label, multi-centre study examining the implementation of LA intra-muscular (IM) drugs in clinics and decentralised community-based settings in the UK.

Purpose

Implementing Long-Acting Novel Antiretrovirals

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-07-18 00:00:00

Anticipated Date of Last Follow-up
2024-07-04 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2023-12-22 00:00:00

Actual Completion Date
2023-12-22 00:00:00

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All
• Male
• Female
• Cisgender female
• Cisgender male
• Transgender female
• Transgender male

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Not provided

Health status

Study type

Not provided

Enrollment

114

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

SUPLA

Identifier

NCT06507059

Link

https://clinicaltrials.gov/study/NCT06507059

Phase

Phase III

Status

Recruiting

Sponsor

Chang Gung Memorial Hospital

More details

This study aims to determine whether people living with HIV (PLHIV) with suboptimal medical adherence can achieve better viral suppression with long-acting antiretrovirals (LA) compared to all-oral antiretrovirals.

Purpose

Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals

Interventions

Intervention 1

Intervention 2

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-07-19 00:00:00

Anticipated Date of Last Follow-up
2024-08-21 00:00:00

Estimated Primary Completion Date
2025-07-01 00:00:00

Estimated Completion Date
2026-12-31 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Willing to sign the written informed consent form for male and female participants aged 18 and above. * At the time of enrollment, diagnosed with HIV infection for a minimum of 12 months. * Under oral antiretroviral treatment (ART), which can be irregular or interrupted, with the most recent viral load ≥ 200 copies/mL. * Body weight ≥ 35Kg. * Willing to maintain contact with the research team throughout the study (provide accurate and reachable phone numbers, social accounts like Line, or reliable contact information of family or friends). * Willing to receive gluteal (buttocks) drug injections. * Willing to transition back to oral medication or follow the recommended treatment prescription according to the then-current national treatment guidelines after discontinua

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

40

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

GLACIER

Identifier

NCT04982445

Link

https://clinicaltrials.gov/study/NCT04982445

Phase

Marketed

Status

Completed

Sponsor

ViiV Healthcare

More details

GLACIER (Giving Long Acting CABENUVA in an Infusion center/ASA) is an interventional study examining the administration of CABENUVA (Cabotegravir long acting \[LA\] plus Rilpivirine LA) intramuscular (IM) in infusion centers/ASAs in United States. In this study, the intervention is the process of using an infusion center/ASA as the location to receive the CABENUVA IM injections. The acceptability and feasibility of the IC/ASA to deliver CABENUVA IM injections will be assessed from the perspectives of the participants, HIV care providers and IC/ASA staff. In this study, Month 1 is the Baseline visit. CABENUVA is a registered trademark of ViiV Healthcare.

Purpose

Study Using CABENUVA™ for the Treatment of Human Immunodeficiency Virus (HIV)-1, Administered in Infusion Centers (IC) or Alternate Sites of Administration (ASA) in the United States (U.S.)

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-11-18 00:00:00

Anticipated Date of Last Follow-up
2025-03-18 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2024-01-31 00:00:00

Actual Completion Date
2024-01-31 00:00:00

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion criteria * Adults (greater than or equal to \[\>=\]18 years old) at the time of signing the informed consent. * HIV-1 infected and have been prescribed CABNEUVA per the United States Prescribing information (USPI). * Participants can be enrolled * If they have been taking oral VOCABRIA + EDURANT or other ART for approximately 1 month (at least 28 days) prior to Baseline/Month 1, or * Already taking CABENUVA prior to Baseline/Month 1 and the last injections were within a 1 month +/- 7-day window or for every 2-month injections, the timing will vary if they are receiving the initiation injections (1 month +/- 7-day) or the continuation injections (2 months +/- 7 days) per the USPI, or * Prescribed direct to inject and receive their 1st injection without an oral lead in at the Infu

Health status

Study type

Interventional (clinical trial)

Enrollment

44

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

The Cheeky Study

Identifier

NCT05979714

Link

https://clinicaltrials.gov/study/NCT05979714

Phase

Marketed

Status

Active, not recruiting

Sponsor

Public Health Foundation Enterprises, Inc.

More details

This is a single-arm implementation study of a novel integrated delivery model of CAB-RPV LA for transwomen living with HIV.

Purpose

The Cheeky Study: A Novel Delivery System for CAB-RPV LA

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-05-31 00:00:00

Anticipated Date of Last Follow-up
2024-08-01 00:00:00

Estimated Primary Completion Date
2024-12-01 00:00:00

Estimated Completion Date
2024-12-01 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Male

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Age 18 years or older * Male sex at birth and gender identity other than male * Willing and able to provide written informed consent * HIV-infected, confirmed by laboratory testing (can be via medical record) * Eligible to receive CAB-RPV LA per FDA-approved label * Virologically suppressed at the last visit within the last 6 months (HIV RNA \<50 copies/ml) * Interested in initiating CAB-RPV LA for HIV treatment and willing to receive injections at Bridge HIV * Currently receiving HIV care by a care provider at one of the collaborating primary care clinics. * Has a cell phone and active service * Able to understand, read, and speak English Exclusion Criteria: * Unable to receive gluteal injections * Plans to move away from the site area within the next 9 months. *

Health status

Study type

Interventional (clinical trial)

Enrollment

50

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Not provided

Key resources

CHEERS

Identifier

NCT06565013

Link

https://clinicaltrials.gov/study/NCT06565013

Phase

Marketed

Status

Not yet recruiting

Sponsor

Clinique Médicale L'Actuel

More details

CHEERS is an observational cohort for people living with HIV who are actively practicing chemsex and who are switching to CAB + RPV LA after being virologically suppressed on a stable oral ART regimen. This study aim to assess the impact of increased patient engagement associated with this LA regimen on linkage to psychosocial care and on global health outcomes, such as quality of life, substance use, treatment satisfaction and virological control. Eligible participants will need to be currently out of care for psychosocial counselling and will need to express the wish to switch to CAB + RPV LA. The participants will be followed in this study for 11 months from their first LA administration, according to the schedule of injections. In addition to standard of care procedures, such as blood

Purpose

Chemsex Health Evaluation With Extended Release System for HIV Treatment

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-08-01 00:00:00

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-08-19 00:00:00

Estimated Primary Completion Date
2026-02-01 00:00:00

Estimated Completion Date
2026-02-01 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Male

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Study type

Not provided

Enrollment

50

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CARLA

Identifier

NCT05156658

Link

https://clinicaltrials.gov/study/NCT05156658

Phase

Marketed

Status

Withdrawn

Sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

More details

The purpose of this pharmacokinetic (PK) trial is to evaluate whether the ENG implant, a long-acting birth control method, is tolerable and effective for adults with HIV who are taking long-acting cabotegravir (CAB-LA) and long-acting rilpivirine (RPV-LA). Access to safe and effective birth control for adults with HIV is important because it may result in fewer infants exposed to HIV in the womb or born with HIV. Researchers believe that people of childbearing potential need access to birth control options that do not need to be negotiated with a partner.

Purpose

Pharmacokinetic Interactions of ENG Subdermal Implants with Long-Acting Cabotegravir (CAB-LA) and LA Rilpivirine (RPV-LA) (CARLA)

Interventions

Not provided

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-01-01 00:00:00

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-12-10 00:00:00

Estimated Primary Completion Date
2024-08-02 00:00:00

Estimated Completion Date
2024-08-02 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Female

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Last menstrual period started ≤35 days prior to study entry. If the start of the last menstrual period was \>35 days prior to study entry, and the individual has been using hormonal contraception for at least 30 days prior to study entry, individual is eligible. If the start of the last menstrual period was \>35 days prior to study entry, and the individual has not been using hormonal contraception for at least 30 days prior to study entry, serum follicle-stimulating hormone (FSH) must be ≤40 mIU/mL. * Negative serum or urine pregnancy test (urine test must have a sensitivity of ≤25 mIU/mL) within 48 hours prior to study entry by any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or is using a poi

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

Not provided

Allocation

Not provided

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

JABS

Identifier

ACTRN12622000105741

Link

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383336

Phase

Marketed

Status

Completed

Sponsor

ViiV Healthcare

More details

Open label, single arm interventional clinical trial of long acting cabotegravir 600mg and long acting rilpivirine 900mg administered by intramuscular injections every two months for a total of 12 months in subjects on standard of care oral regimens, including those with complex medical and social vulnerability factors. Adherence with treatment will be monitored using records of clinic attendance and administration of injections.

Purpose

Feasibility and effectiveness of long acting cabotegravir and rilpivirine for treatment of HIV infection in patients with complex needs.

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-02-10 00:00:00

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2023-05-25 00:00:00

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Male
• Female

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

• Aged 18 years or older at the time of signing the informed consent. • Have HIV infection treated with a standard combination antiretroviral regimen for at least 6 months prior to screening. • Documented evidence of at least one plasma HIV-1 RNA measurement <40 cps/mL in the 24 weeks prior to screening and within 4 weeks of enrolment. • A female participant with reproductive potential but using acceptable forms of contraception is eligible to participate

Health status

Study type

Not provided

Enrollment

Not provided

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

EMPOWER (GS-US-380-6738)

Identifier

NCT06104306

Link

https://clinicaltrials.gov/study/NCT06104306

Phase

Marketed

Status

Completed

Sponsor

Gilead Sciences

More details

The goal of this clinical study is to learn how safe and effective it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in participants living with virologically suppressed human immunodeficiency virus type 1 (HIV-1), meaning participants with HIV RNA levels below detectable levels. The primary objective of this study is to assess the safety of switching to B/F/TAF in virologically suppressed participants unable/unwilling to continue on CAB+RPV intramuscular (IM) injections or wishing to switch to oral therapy through Week 12.

Purpose

Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-12-13 00:00:00

Anticipated Date of Last Follow-up
2025-05-05 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2025-01-29 00:00:00

Actual Completion Date
2025-04-23 00:00:00

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Key Inclusion Criteria: * People with HIV-1 (PWH) or provider decision to switch off CAB+RPV IM injections due to intolerance, inconvenience, adverse events (AEs), or willing to switch to (and intention to remain on) daily B/F/TAF * Currently virologically suppressed (HIV-1 RNA \< 50 copies/mL) on CAB+RPV IM injections every 2 months * Currently on CAB+RPV IM injections every 2 months and received at least one dose of CAB+RPV IM injection; no missed CAB+RPV injections * Ability to receive B/F/TAF up to 7 days prior to the next scheduled dose of CAB+RPV * Documented plasma HIV-1 RNA \< 50 copies/mL during treatment for ≥ 6 months preceding the screening visit * No documented or suspected resistance to BIC, emtricitabine (FTC), or tenofovir (TFV). Key Exclusion Criteria: * History of B/F/

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

33

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

IMPAACT 2036

Identifier

NCT05660980

Link

https://clinicaltrials.gov/study/NCT05660980

Phase

Phase I/II

Status

Recruiting

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

More details

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age

Purpose

Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-01-24 00:00:00

Anticipated Date of Last Follow-up
2025-05-23 00:00:00

Estimated Primary Completion Date
2026-06-15 00:00:00

Estimated Completion Date
2027-07-27 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria, Step 1: Entry for Cohort 1, Cohort 2a, and Cohort 2b * Parent or legal guardian is willing and able to provide written permission for child's study participation and, when applicable per institutional review board/ethics committee (IRB/EC) policies and procedures, child is willing and able to provide written assent for study participation. Note: All sites must follow all applicable IRB/EC policies and procedures; for US sites, this includes single IRB (sIRB) policies and procedures. * Age two years old to less than 12 years old at entry * Body weight ≥10 kgs and \<40 kgs at entry * At entry, willing and able to comply with the study visit schedule and other study requirements, as determined by the site investigator or designee. * Confirmed HIV-1-infection based on do

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

90

Allocation

Not provided

Intervention model

Sequential assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CREATE

Identifier

NCT06062979

Link

https://clinicaltrials.gov/study/NCT06062979

Phase

Marketed

Status

Enrolling by invitation

Sponsor

Whitman-Walker Institute

More details

The purpose of this study is to assess adherence to home-delivered long-acting injectable rilpivirine/cabotegravir (Cabenuva) among people living with HIV enrolled in the Mobile Outreach Retention and Engagement (MORE) program at Whitman-Walker Health due to significant barriers to being retained in care; the MORE program provides supportive services including dedicated care navigation, transportation assistance, and mobile/home-delivered care. The investigators will examine the equivalence of treatment outcomes among patients receiving injectable treatment within the MORE program as compared to those of patients receiving Cabenuva in standard care at Whitman-Walker Health.

Purpose

Clinical Effectiveness-Implementation Hybrid Type 2 Study on Home-Delivered Cabenuva for People Living With HIV Who Are Not Retained in Care

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-01 00:00:00

Anticipated Date of Last Follow-up
2024-04-23 00:00:00

Estimated Primary Completion Date
2025-06-30 00:00:00

Estimated Completion Date
2025-06-30 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

180

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

EXPAND

Identifier

NCT06635421

Link

https://clinicaltrials.gov/study/NCT06635421

Phase

Marketed

Status

Not yet recruiting

Sponsor

MetroHealth Medical Center

More details

The purpose of The EXPAND study is to develop and pilot a pharmacist led model of medication delivery. Following a co-design phase, patients may receive injections at satellite pharmacies by a licensed pharmacist. The acceptability, appropriateness, and feasibility of this approach and standard in clinic administration by a nurse will be assessed.

Purpose

The Expand Study-Pharmacist Administered Long Acting Cabotegravir + Rilpivirine to Expand Access for People With HIV

Interventions

Not provided

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-11-01 00:00:00

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-10-08 00:00:00

Estimated Primary Completion Date
2026-12-31 00:00:00

Estimated Completion Date
2026-12-31 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

164

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Non-Probability Sample

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CARES

Identifier

PACTR202104874490818

Link

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15757

Phase

Marketed

Status

Active, not recruiting

Sponsor

Joint Clinical Research Centre, Kampala, Uganda

More details

Primary objective: To demonstrate the non-inferior antiviral activity of switching to IM RPV LA+CAB LA administered every 2 months compared with continuation of cART administered daily over 12 months in HIV-1 infected participants in a resource limited setting Secondary objectives: 1. To demonstrate the antiviral and immunologic activity of switching to IM RPV LA+CAB LA every 2 months compared to continuation of cART over 12 and 24 months of follow-up. 2. To evaluate the safety and tolerability of switching to RPV LA+CAB LA every 2 months compared to continuation of cART. 3. To assess viral resistance in participants experiencing protocol-defined confirmed virologic failure(plasma HIV-1 RNA ≥200 c/mL). 4. To assess the incidence of on-treatment genotypic resistance to CAB, RPV and other on

Purpose

Cabotegravir And Rilpivirine: Efficacy and Safety Study (CARES)

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-09-15 00:00:00

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2024-08-20 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Not provided

Health status

Study type

Interventional (clinical trial)

Enrollment

512

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CALENDULA

Identifier

NCT06657885

Link

https://clinicaltrials.gov/study/NCT06657885

Phase

Phase II

Status

Not yet recruiting

Sponsor

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

More details

This study is a Phase II, prospective, single-arm, multicenter, non-randomized pilot study designed to evaluate the antiretroviral efficacy of lenacapavir in combination with cabotegravir injection over 48 weeks of follow-up in participants who meet the study inclusion criteria. Efficacy is defined as the absence of virologic failure at S48. Virologic success is defined as maintaining or achieving CV \< 50 copies/mL without interruption of long-acting dual therapy with cabotegravir/lenacapavir at the end of 48 weeks. The study will be conducted at several sites in France in adults 18 years of age and older. Minors and persons under legal guardianship will not be included in the study. Long-acting treatments are evolving thanks to new "long-acting" molecules. These molecules ensure prolong

Purpose

CAbotégravir LENacapavir DUal Long Acting

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2025-01-15 00:00:00

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-10-23 00:00:00

Estimated Primary Completion Date
2026-07-15 00:00:00

Estimated Completion Date
2026-09-15 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Inclusion: - Age ≥ 18 years - HIV-1 infection - Stable oral antiretroviral treatment for at least 6 months - Multi-treated patients who have received multiple lines of antiretroviral treatment - Undetectable patients with CV \< 50 copies/mL in the last 6 months (a single blip between 50 and 200 copies/mL in the last 6 months is allowed) and eligible to switch to the lenacapavir/cabotegravir strategy on the basis of a collegial decision by clinicians, virologists and pharmacologists following a multidisciplinary meeting due to the presence of resistance mutations, including to NNRTIs, oral drug intolerance or drug-drug interactions - Detectable, virologically uncontrolled HIV viral load ≥ 200 c/mL in the last 12 months who is eligible to switch to the lenacapavir/cabotegravir strategy

Health status

Study type

Interventional (clinical trial)

Enrollment

30

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

NCT06970223

Identifier

NCT06970223

Link

https://clinicaltrials.gov/study/NCT06970223

Phase

Phase I

Status

Recruiting

Sponsor

ViiV Healthcare

More details

This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.

Purpose

A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-04-22 00:00:00

Anticipated Date of Last Follow-up
2025-05-05 00:00:00

Estimated Primary Completion Date
2025-07-30 00:00:00

Estimated Completion Date
2026-07-07 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: 1. At the time of obtaining informed consent, 18 years of age. 2. Body weight 50 kg and BMI within the range 18 to 32 kg/m2 (inclusive). 3. Participants who are overtly healthy as determined by medical evaluation by a responsible and experienced physician, including medical history, physical examination, laboratory tests and cardiac monitoring. 4. A participant with a significant clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included if the investigator determines and documents that the finding is unlikely to introduce additional

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

60

Allocation

Randomized

Intervention model

Cross-over assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

EXTEND4M

Identifier

NCT06741397

Link

https://clinicaltrials.gov/study/NCT06741397

Phase

Phase II

Status

Active, not recruiting

Sponsor

ViiV Healthcare

More details

A single arm, repeat dose study to evaluate the pharmacokinetic profile, safety, and tolerability of a new formulation of cabotegravir LA injected intramuscularly Q4M in adolescent and adult participants at risk of HIV acquisition.

Purpose

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-12-20 00:00:00

Anticipated Date of Last Follow-up
2025-06-16 00:00:00

Estimated Primary Completion Date
2026-09-09 00:00:00

Estimated Completion Date
2029-01-10 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: 1. At the time of obtaining informed consent, adolescent and adult participants weighing at least 35 kg. 2. Participants must have a nonreactive HIV test at Screening (rapid test, nonrapid HIV immunoassay, and HIV RNA) and enrollment (a rapid test, nonrapid HIV immunoassay, and HIV RNA). 3. Participants who are at risk of acquiring HIV, defined as having had anal or vaginal sex in the past 6 months. 4. Participants who are overtly healthy as determined by medical evaluation by a responsible and experienced physician, including medical history, physical examination, laboratory tests and cardiac monitoring at the time of screening. 5. No alcohol or substance use that, in the opinion of the study investigator and medical monitor, would interfere with the study.

Health status

Study type

Interventional (clinical trial)

Enrollment

228

Allocation

Randomized

Intervention model

Single group assignment

Intervention model description

Key end point: CAB trough concentrations Participants receive lead-in injections comprising cabotegravir LA during month one and injections of a new formulation of CAB LA at Month 3, Month 5 and every 4 months thereafter to Month 29

Masking

Open label

Masking description

This is an open label study.

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

Switch from CAB LA to CAB ULA

Identifier

NCT06786520

Link

https://clinicaltrials.gov/study/NCT06786520

Phase

Phase I

Status

Active, not recruiting

Sponsor

ViiV Healthcare

More details

A single arm, repeat dose study to evaluate the pharmacokinetics, safety, and tolerability of switching to cabotegravir long-acting 4-monthly formulation (CAB Q4M) from cabotegravir long-acting (CAB LA 2M) in healthy adult volunteers

Purpose

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-01-17 00:00:00

Anticipated Date of Last Follow-up
2025-06-16 00:00:00

Estimated Primary Completion Date
2027-03-09 00:00:00

Estimated Completion Date
2027-11-08 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Adult participants greater than or equal to (\>=) 18 years old, weighing at least 35 kg. * Participants who are overtly healthy as determined by medical evaluation. * Assigned male sex at birth or assigned female sex at birth. Participants assigned female sex at birth are eligible to participate if they are of non-childbearing potential, or if they are of childbearing potential and are not pregnant (confirmed by test), not breastfeeding, and are using a highly effective contraceptive method. * Capable of giving written informed consent.

Health status

Study type

Interventional (clinical trial)

Enrollment

69

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Participants will receive the CAB LA Q2M regimen up to Month 9 then will receive the CAB ULA Q4M regimen up to Month 23. Key end points are plasma concentration of CAB at the end of the CAB LA 2M phase compared to plasma concentration of CAB at the end of the CAB Q4M phase

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

ECLAIR

Identifier

NCT02076178

Link

https://clinicaltrials.gov/study/NCT02076178

Phase

Phase II

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate the safety, tolerability and acceptability of long acting injections of the HIV integrase inhibitor, GSK1265744, in HIV-uninfected men.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2014-03-27 00:00:00

Anticipated Date of Last Follow-up
2017-12-13 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2015-05-15 00:00:00

Actual Completion Date
2016-02-23 00:00:00

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Cisgender male
• Transgender male

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: - Non-reactive HIV test at screening or enrollment. - Males 18 to 65 years old at the time of signing the informed consent. - At risk of acquiring HIV, defined as having at least one casual sex partner in the past 24 months. - Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring at the time of screening. - If participating in sexual activity with a female of child-bearing potential, men must agree to use condoms. Female partner must use contraception. - Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. - Willing to undergo all required study procedures.

Health status

Study type

Interventional (clinical trial)

Enrollment

127

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Double (Participant, Investigator)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

HPTN 077

Identifier

NCT02178800

Link

https://clinicaltrials.gov/study/NCT02178800

Phase

Phase II

Status

Completed

Sponsor

National Institute of Allergy and Infectious Diseases

More details

Not provided

Purpose

Evaluate the safety, tolerability, and pharmacokinetics of an investigational, injectable HIV medicine (GSK1265744) in HIV-uninfected adults.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2015-02-01 00:00:00

Anticipated Date of Last Follow-up
2021-10-14 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2017-04-05 00:00:00

Actual Completion Date
2018-07-13 00:00:00

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Men and women, 18 to 65 years old at the time of screening, who are willing to provide informed consent for the study. Participants are required to be in general good health, as confirmed by laboratory investigation, with no medical condition(s) that would interfere with the conduct of the study.

Health status

Study type

Interventional (clinical trial)

Enrollment

199

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

HPTN 083

Identifier

NCT02720094

Link

https://clinicaltrials.gov/study/NCT02720094

Phase

Phase II/III

Status

Not provided

Sponsor

National Institute of Allergy and Infectious Diseases

More details

Not provided

Purpose

Evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2016-12-01 00:00:00

Anticipated Date of Last Follow-up
2024-11-07 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-04-30 00:00:00

Actual Primary Completion Date
2020-05-14 00:00:00

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Cisgender male
• Transgender female

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

HIV negative cis-gender men and transgender women (18 years or older at the time of screening [assigned male at birth]) who have sex with men and at high risk of HIV infection.

Health status

Study type

Interventional (clinical trial)

Enrollment

4570

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

HPTN 084

Identifier

NCT03164564

Link

https://clinicaltrials.gov/study/NCT03164564

Phase

Phase III

Status

Not provided

Sponsor

National Institute of Allergy and Infectious Diseases

More details

Not provided

Purpose

Evaluate the safety and efficacy of CAB LA compared to daily oral tenofovir disoproxil fumarate/emtricitabine for PrEP in HIV-uninfected women.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2017-11-07 00:00:00

Anticipated Date of Last Follow-up
2024-09-26 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2024-11-30 00:00:00

Actual Primary Completion Date
2020-11-05 00:00:00

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• Cisgender female

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Born female and 18-45 years of age at the time of screening. Must have documented evidence of surgical sterilization, OR documented evidence of no uterus (e.g., hysterectomy), OR must agree to use a reliable form of long acting contraception, during the trial and for 52 weeks after stopping the long acting injectable, or 30 days after stopping oral study product

Health status

Study type

Interventional (clinical trial)

Enrollment

3224

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

EBONI

Identifier

NCT05514509

Link

https://clinicaltrials.gov/study/NCT05514509

Phase

Marketed

Status

Not provided

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate implementation strategies for the delivery of CAB for HIV PrEP across clinical settings for adult (≥18 Years) black cis-and transgender women without HIV infection living in the United States

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-10-28 00:00:00

Anticipated Date of Last Follow-up
2025-06-17 00:00:00

Estimated Primary Completion Date
2025-08-29 00:00:00

Estimated Completion Date
2025-08-29 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Cisgender female
• Transgender female

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion criteria: - Participant must be ≥18 years of age, at the time of signing the informed consent. - HIV negative at screening. Type of HIV-1 test is per standard of care. - No prior history of receiving oral CAB or CAB LA injections. - PrEP provider deems CAB PrEP use to be appropriate per the applicable CAB PrEP prescribing information prior to enrollment in the study. - Female at birth or self-identified Transgender Female. - Self-identified as African American/Black. - Capable of giving signed informed consent.

Health status

Study type

Interventional (clinical trial)

Enrollment

156

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

PILLAR

Identifier

NCT05374525

Link

https://clinicaltrials.gov/study/NCT05374525

Phase

Marketed

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate implementation strategies for the delivery of cabotegravir PrEP for HIV uninfected MSM and transgender men ≥ 18 in the United States.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-05-18 00:00:00

Anticipated Date of Last Follow-up
2025-01-09 00:00:00

Estimated Primary Completion Date
2024-09-06 00:00:00

Estimated Completion Date
2024-09-06 00:00:00

Actual Primary Completion Date
2024-08-08 00:00:00

Actual Completion Date
2024-08-08 00:00:00

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Cisgender male
• Transgender male

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Not provided

Health status

Study type

Interventional (clinical trial)

Enrollment

201

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

ImPrEP

Identifier

NCT05515770

Link

https://clinicaltrials.gov/study/NCT05515770

Phase

Phase III

Status

Recruiting

Sponsor

Evandro Chagas National Institute of Infectious Disease

More details

Not provided

Purpose

Assess the safety and effectiveness of open label CAB LA PrEP when offered at public health facilities to cisgender men and transgender or gender non-binary individuals who have sex with men.

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2022-09-20 00:00:00

Actual Start Date
2022-09-20 00:00:00

Anticipated Date of Last Follow-up
2024-10-03 00:00:00

Estimated Primary Completion Date
2025-10-01 00:00:00

Estimated Completion Date
2026-02-01 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• Cisgender male
• Transgender female
• Transgender male
• Gender non-binary

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Cisgender men, non-binary (assigned as male at birth), transgender women and transgender men who are seeking a PrEP study clinic and age 18-30 years. Study participants must report having anal sex in the last six months with a person assigned male gender at birth.

Health status

Study type

Interventional (clinical trial)

Enrollment

1200

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Methods include qualitative (focus group discussion and in-depth interviews) and quantitative (service statistics, laboratory tests, surveys) approaches. The incidence of HIV in the CAB LA study cohort will be evaluated against a similar cohort receiving oral PrEP. Interrupted time series analysis will be utilised to assess the effectiveness of the mHealth intervention.

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

SEARCH SAPPHIRE DCP Extension

Identifier

NCT05549726

Link

https://clinicaltrials.gov/study/NCT05549726

Phase

Marketed

Status

Completed

Sponsor

University of California, San Francisco

More details

Not provided

Purpose

Determine whether adding the option of CAB-LA as HIV PrEP increases prevention coverage compared to the standard-of-care in three ongoing randomized trials of dynamic choice in rural Uganda and Kenya.

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-01-02 00:00:00

Anticipated Date of Last Follow-up
2025-01-30 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-01-01 00:00:00

Actual Primary Completion Date
2023-12-18 00:00:00

Actual Completion Date
2025-01-30 00:00:00

Studied populations

Age Cohort

• Adolescents
• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Participants must be enrolled in a SEARCH Sapphire Dynamic prevention study (NCT04810650).

Health status

Study type

Interventional (clinical trial)

Enrollment

984

Allocation

Non-randomized

Intervention model

Parallel Assignment

Intervention model description

CAB-LA will be offered to participants that are initially assigned to the Dynamic Choice Prevention delivery model.

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

NCT02478463

Identifier

NCT02478463

Link

https://clinicaltrials.gov/study/NCT02478463

Phase

Phase I

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Determine the PK concentrations of CAB following LA administration in relevant tissues and fluids of healthy men and women following a single 600 mg IM dose.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2017-02-27 00:00:00

Anticipated Date of Last Follow-up
2020-06-02 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2019-07-25 00:00:00

Actual Completion Date
2019-07-25 00:00:00

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: - Between 18 and 55 years of age inclusive, at the time of signing the informed consent. - Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - Body weight >= 40 kilogram (kg) and body mass index (BMI) within the range 18.5 to 35 kg /meter square (inclusive). - Male or female. - Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. - All subjects participating in the study must be counselled on safe sexual practices including the use of effective barrier methods to minimize risk of HIV transmission.

Health status

Study type

Interventional (clinical trial)

Enrollment

19

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

NCT03422172

Identifier

NCT03422172

Link

https://clinicaltrials.gov/study/NCT03422172

Phase

Phase I

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate the PK, safety, tolerability, and acceptability of CAB LA in adult HIV uninfected Chinese male subjects at low risk for HIV acquisition.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2018-04-10 00:00:00

Anticipated Date of Last Follow-up
2021-05-12 00:00:00

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2020-04-20 00:00:00

Actual Completion Date
2020-04-20 00:00:00

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Cisgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: - Subjects must be 18 to 65 years of age inclusive, at the time of signing the informed consent. - Subjects are male at birth. - Subjects who have non-reactive point of care (POC) HIV test and undetectable HIV-1 ribose nucleic acid (RNA) at screening. - At risk of acquiring HIV, defined as having at least one casual male or female sex partner in the past 24 months. - Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring at the time of screening. - Capable of giving written informed consent. - Agree to appropriate use of contraceptive measures during heterosexual intercourse. - Willing to undergo all required study procedures.

Health status

Study type

Interventional (clinical trial)

Enrollment

48

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Eligible subjects will receive oral doses of CAB for 4 weeks followed by IM dosing with CAB LA at Week 5, Week 9, Week 17, Week 25 and Week 33.

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

PALISADE

Identifier

NCT06134362

Link

https://clinicaltrials.gov/study/NCT06134362

Phase

Phase III

Status

Recruiting

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Long-term follow-up and evaluation of CAB LA for participants in the HPTN 083 and HPTN 084 CAB PrEP studies who are at risk of HIV acquisition.

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-04-01 00:00:00

Actual Start Date
2024-05-24 00:00:00

Anticipated Date of Last Follow-up
2025-06-16 00:00:00

Estimated Primary Completion Date
2028-06-26 00:00:00

Estimated Completion Date
2028-06-26 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Adolescents
• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Yes

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Participants must be currently enrolled and ongoing in one of the following studies: (1) HPTN 083 (2) HPTN 084 (3) HPTN 083 and HPTN 084 adolescent and pregnancy sub-studies Participants who have permanently withdrawn from prior CAB PrEP studies cannot enroll into this study.

Health status

Study type

Interventional (clinical trial)

Enrollment

3500

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

TSHIRELETSO

Identifier

NCT05986084

Link

https://clinicaltrials.gov/study/NCT05986084

Phase

Marketed

Status

Recruiting

Sponsor

Beth Israel Deaconess Medical Center

More details

Not provided

Purpose

aluate whether using long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and safe in postpartum people who are breastfeeding.

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-30 00:00:00

Anticipated Date of Last Follow-up
2025-04-23 00:00:00

Estimated Primary Completion Date
2027-08-31 00:00:00

Estimated Completion Date
2027-08-31 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Cisgender female

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Yes

Accepts healthy individuals
No

Comments about the studied populations

Participants are postpartum (< 14 days after delivery) mothers who are aged 18-30 with less than a total of three prior pregnancies. Participants should plan to stay and receive postpartum and paediatric care in the Gaborone or Molepolole region of Botswana for at least 24 months.

Health status

Study type

Interventional (clinical trial)

Enrollment

500

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

AXIS

Identifier

NCT06138600

Link

https://clinicaltrials.gov/study/NCT06138600

Phase

Phase III

Status

Not provided

Sponsor

University of Witwatersrand, South Africa

More details

This is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting Pre-exposure Prophylaxis at private pharmacies, who will be offered either Cabotegravir Long-Acting Injectable, oral Pre-exposure Prophylaxis (TDF/FTC\[3TC\]), or Pre-exposure Prophylaxis deferment at each of their regular visits, with the option to switch between options for up to 15 months, with a final exit interview following the transition to standard-of-care. The number of study visits will vary, depending on participant Pre-exposure Prophylaxis choices. Those choosing oral Pre-exposure Prophylaxis will be seen 3 monthly from V2 onwards, but those choosing Cabotegravir Long-Acting Injectable will be seen 2 monthly from V2. A maximum

Purpose

Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-01 00:00:00

Anticipated Date of Last Follow-up
2024-06-19 00:00:00

Estimated Primary Completion Date
2025-10-31 00:00:00

Estimated Completion Date
2026-01-31 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion criteria: - Each participant must meet all of the following criteria to be enrolled in this study: 1. Adult male or female (≥18 and ≤ 35 years old) 2. Is self-reported sexually active 3. HIV negative at the time of study enrolment (as determined by a rapid blood test for HIV 1) 4. Body weight ≥ 35 kilograms. 5. Creatinine clearance ≥ 60 mL/min. 6. Willingness to sign informed consent.

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

200

Allocation

Non-randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

PEACH

Identifier

NCT05072093

Link

https://clinicaltrials.gov/study/NCT05072093

Phase

Marketed

Status

Completed

Sponsor

Emory University

More details

The study is a prospective cohort of young MSM who are followed for 2 years either in-person at the PRISM Health Research Clinic and/or virtually with telehealth study visits. Follow-up visits occur as frequently as every 3 months, or as appropriate to clinical needs of HIV PrEP or STI PEP. The investigators will enroll men who may decide to start or stop PrEP, change from daily oral PrEP to on-demand oral PrEP or from on-demand oral PrEP to daily PrEP, to start or stop STI PEP at any point in the study period, or injectable PrEP as an alternative to daily oral PrEP or on-demand oral PrEP. All men will be provided with the study's mobile smart phone app to support early identification of risks for PrEP discontinuation, to provide information about STI PEP and document usage patterns of on-

Purpose

Parrying the Pitfalls of PrEP: Project PEACH

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-11-20 00:00:00

Anticipated Date of Last Follow-up
2025-05-29 00:00:00

Estimated Primary Completion Date
2025-02-01 00:00:00

Estimated Completion Date
2025-02-01 00:00:00

Actual Primary Completion Date
2025-03-31 00:00:00

Actual Completion Date
2025-03-31 00:00:00

Studied populations

Age Cohort

• Adults

Genders

• Male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Male at birth * Self-identify as Cisgender Male * Ages 18-45 years * ≥1 male anal sex partner in the 12 months before the baseline interview * Live in the Atlanta MSA * Owns cell phone with data service * Willing to download a health-related app to their cell phone as part of the research study * Able to provide ≥ 2 means of contact * Not currently enrolled in another HIV prevention clinical trial * Confirmed HIV-negative at baseline visit Exclusion Criteria: * Female at birth * Do not self-identify as Cisgender Male * Individuals \< 18 years of age or \> 45 years of age * HIV positive status * No male anal sex partner in the 12 months before the baseline interview * Does not own mobile phone with data service * Not willing to download a health-related app to their

Health status

Study type

Interventional (clinical trial)

Enrollment

240

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

MOBILEMEN

Identifier

NCT06133686

Link

https://clinicaltrials.gov/study/NCT06133686

Phase

Phase III

Status

Not yet recruiting

Sponsor

MRC/UVRI and LSHTM Uganda Research Unit

More details

Title: Implementing oral (event-driven and daily) and long-acting Pre-exposure prophylaxis (PrEP) in mobile men in Sub-Saharan Africa Design: A mixed method, multi-setting, multi-country, phase 3b, open-label, hybrid type 2 implementation and effectiveness randomized controlled trial (RCT). The trial will be carried out in 400 HIV negative men aged 18+ years in South Africa and Uganda. Men will be randomized 1:1 to either Group A: oral Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) PrEP (event-driven or daily) or Group B: Long-acting injectable cabotegravir (CAB-LA) over 9-months. After 9-months participants from both groups will be offered choice of PrEP (oral TDF-FTC or CAB-LA) for a further 9-months, with the ability to change choice as required. Various strategies to support Pr

Purpose

Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-04-01 00:00:00

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2023-11-13 00:00:00

Estimated Primary Completion Date
2025-12-31 00:00:00

Estimated Completion Date
2027-04-01 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• Male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: 1. Able and willing to provide informed consent 2. Aged 18 years and above on the day of screening 3. Willing to have a HIV test and receive the test results 4. Male at birth 5. In the past 6-months has travelled for work or to find work and spent at least one night away from home for work related purposes. 6. Available for follow up for the duration of the study Exclusion Criteria: 1. Known HIV infection 2. Confirmed HIV-positive test result, indeterminate HIV test result, and/or signs and symptoms of an acute HIV infection 3. Body weight less than 35Kg at baseline 4. Allergy to any of the study products 5. Medical, social or other condition that, in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (e.g

Health status

Study type

Interventional (clinical trial)

Enrollment

400

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

PathToScale

Identifier

NCT06319105

Link

https://clinicaltrials.gov/study/NCT06319105

Phase

Marketed

Status

Recruiting

Sponsor

Georgetown University

More details

The purpose of this study is to evaluate the implementation and clinical outcomes of expanded pre-exposure prophylaxis delivery modalities and service delivery points offering long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high-priority groups through diverse delivery channels.

Purpose

PathToScale: An Implementation Evaluation

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-03-26 00:00:00

Anticipated Date of Last Follow-up
2024-03-28 00:00:00

Estimated Primary Completion Date
2026-04-01 00:00:00

Estimated Completion Date
2026-04-01 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Observational studies (incl. patient registries)

Enrollment

9900

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

IDCaPP

Identifier

NCT05867212

Link

https://clinicaltrials.gov/study/NCT05867212

Phase

Marketed

Status

Not yet recruiting

Sponsor

Kelley-Ross & Associates, Inc.

More details

The goal of this demonstration project or observational study is to evaluate the feasibility and acceptability of a pharmacist-managed cabotegravir long acting injectable for PrEP program in a community pharmacy setting. The main question it aims to answer are: * Is the program feasible and acceptable at the end of 1 year of operations? * What are the facilitators and barriers of the program? Participants who want to start the FDA approved cabotegravir long acting injectable medication for PrEP will have the option participating in surveys and a review of their electronic health records. Medication will be administered based on FDA approved labeling guidelines and their PrEP care will be part of standard of care per CDC. Pharmacists who want to provide the service to their patients will

Purpose

Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2023-06-01 00:00:00

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2023-05-16 00:00:00

Estimated Primary Completion Date
2025-11-30 00:00:00

Estimated Completion Date
2025-11-30 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
Yes

Accepts lactating individuals
Yes

Accepts healthy individuals
Yes

Comments about the studied populations

Not provided

Health status

Study type

Observational studies (incl. patient registries)

Enrollment

50

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

HIPCY

Identifier

NCT06474364

Link

https://clinicaltrials.gov/study/NCT06474364

Phase

Marketed

Status

Not yet recruiting

Sponsor

MU-JHU CARE

More details

Several studies show that Adolescents and Young Adults (AYA) have poor outcomes along the entire Human Immunodeficiency Virus (HIV) prevention and care cascades compared to adults. The investigators propose to evaluate novel evidence-based HIV prevention and care interventions (including Cabotegravir LongActing (CABLA) to determine implementation outcomes among AYA who are at particularly high risk for HIV acquisition and poor viral suppression in five geographically distinct research performance sites in Uganda. The results will provide important evidence to inform Uganda and other regional countries' policy on integrated HIV prevention, care and treatment for AYA at high risk for HIV and Sexually Transmitted Infections (STIs) in order to reach the UNAIDS 95-95-95 targets and HIV epidemic

Purpose

HIV Prevention and Care Interventions for Youth in Uganda

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-07-15 00:00:00

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-06-19 00:00:00

Estimated Primary Completion Date
2028-08-31 00:00:00

Estimated Completion Date
2028-08-31 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adolescents
• Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: Adolescents and young adults with increased likelihood of HIV acquisition * AYA 15 to 24 years of age * Classified as high risk using our screening tool. * Documented HIV un-infected as per the national HIV testing algorithm. * Willing to use PrEP * Willing to provide written informed consent. * No plans to relocate permanently in the next 6 months * No suspicion of acute HIV infection: * Hepatitis B virus surface antigen (HBsAg)-negative and accepts HB vaccination * Having no medical or social condition that, in the opinion of the study investigator, would interfere with the conduct of the study or interpretation of study results. * HIV-uninfected, based on HIV test results obtained at screening and enrolment visit and just prior to randomization. All HIV test res

Health status

Study type

Interventional (clinical trial)

Enrollment

600

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

CATALYST

Identifier

NCT05937698

Link

https://clinicaltrials.gov/study/NCT05937698

Phase

Marketed

Status

Terminated

Sponsor

FHI 360

More details

The CATALYST study is an implementation study that will characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at PEPFAR sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe.

Purpose

The CATALYST Study

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-05-30 00:00:00

Anticipated Date of Last Follow-up
2025-03-12 00:00:00

Estimated Primary Completion Date
2025-06-30 00:00:00

Estimated Completion Date
2025-06-30 00:00:00

Actual Primary Completion Date
2025-01-27 00:00:00

Actual Completion Date
2025-01-27 00:00:00

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Observational studies (incl. patient registries)

Enrollment

6069

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

LAPIS

Identifier

NCT06250504

Link

https://clinicaltrials.gov/study/NCT06250504

Phase

Phase III

Status

Recruiting

Sponsor

Africa Health Research Institute

More details

The goal of this hybrid (1a) Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products (PrEP) through community-based sexual and reproductive health services, on PrEP uptake and retention, and population prevalence of sexually transmissible HIV amongst adolescents and young adults living in rural South Africa. Researchers will compare adding the choice of long-acting PrEP, i.e. two monthly injectable cabotegravir (CAB LA) or dapiravine vaginal ring and HIV post exposure prophylaxis packs to daily oral PrEP integrated with community-based SRH in the 20 intervention clusters with standard of care (SoC), daily oral PrEP integrated with community-based SRH in the 20 control clusters, on uptake and r

Purpose

Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-02-27 00:00:00

Anticipated Date of Last Follow-up
2024-04-16 00:00:00

Estimated Primary Completion Date
2025-07-01 00:00:00

Estimated Completion Date
2026-03-01 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: All young men and women aged 15-30 who are residing in the 40 administrative clusters in the study district and attend any integrated SRH/HIV service Documented HIV negative test Suitable for PrEP and/or already on PrEP Weight \> 35 kg Understand the required dosing schedule and HIV testing. Aware that details can be shared with a peer navigator to support their follow-up If pregnant or breast feeding and/or planning to become pregnant participant can be offered CAB LA, if risk of acquiring HIV out weighs unknown risk of CAB LA, but must understand that safety in pregnancy or breast feeding for CAB LA has not been established and oral daily PrEP is a safe alternative. Exclusion Criteria: History or presence of allergy to the study drugs or their components Inv

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

2000

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

TIARAS-CAB-WWID

Identifier

NCT05799339

Link

https://clinicaltrials.gov/study/NCT05799339

Phase

Marketed

Status

Recruiting

Sponsor

Alexis Roth

More details

The goal of this study is to elicit information crucial for designing strategies to support engagement in cabotegravir, a long-acting injectable form of pre-exposure prophylaxis (PrEP) to reduce HIV risk among women who inject drugs (WWID), a population with high unmet need that has been understudied in all phases of PrEP research. The main questions this study aims to answer are: 1. How do WWID perceive long-acting injectable cabotegravir (CAB-LA) as a HIV prevention tool? 2. If and how their decisions to initiate CAB-LA as PrEP are informed by their experiences with other long-acting medications, experience with daily oral medications, and their personal circumstance (e.g., like housing or addition severity)? 3. Do PrEP outcomes (e.g., adherence) and engagement in care over time differ

Purpose

Optimizing CAB-LA as PrEP for Women Who Inject Drugs

Interventions

Not provided

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-01-13 00:00:00

Anticipated Date of Last Follow-up
2025-02-06 00:00:00

Estimated Primary Completion Date
2025-12-30 00:00:00

Estimated Completion Date
2025-12-30 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• Female

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Women who inject drugs

Health status

Study type

Observational studies (incl. patient registries)

Enrollment

144

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

AXIS

Identifier

NCT06138600

Link

https://clinicaltrials.gov/study/NCT06138600

Phase

Phase III

Status

Not provided

Sponsor

University of Witwatersrand, South Africa

More details

This is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting Pre-exposure Prophylaxis at private pharmacies, who will be offered either Cabotegravir Long-Acting Injectable, oral Pre-exposure Prophylaxis (TDF/FTC\[3TC\]), or Pre-exposure Prophylaxis deferment at each of their regular visits, with the option to switch between options for up to 15 months, with a final exit interview following the transition to standard-of-care. The number of study visits will vary, depending on participant Pre-exposure Prophylaxis choices. Those choosing oral Pre-exposure Prophylaxis will be seen 3 monthly from V2 onwards, but those choosing Cabotegravir Long-Acting Injectable will be seen 2 monthly from V2. A maximum

Purpose

Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-01 00:00:00

Anticipated Date of Last Follow-up
2024-06-19 00:00:00

Estimated Primary Completion Date
2025-10-31 00:00:00

Estimated Completion Date
2026-01-31 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: - Each participant must meet all of the following criteria to be enrolled in this study: 1. Adult male or female (≥18 and ≤ 35 years old) 2. Is self-reported sexually active 3. HIV negative at the time of study enrolment (as determined by a rapid blood test for HIV 1) 4. Body weight ≥ 35 kilograms. 5. Creatinine clearance ≥ 60 mL/min. 6. Willingness to sign informed consent. Exclusion Criteria: - Participants meeting the following criteria will be excluded from participating in the study: 1. Symptoms of HIV seroconversion (see Table 1). 2. Pregnant (participant must have a negative beta human chorionic gonadotrophin (b-hCG) urine test at screening) or lactating women, or women intending to become pregnant or breastfeed during the study. 3. Is in good health, with

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

200

Allocation

Not provided

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

NCT06970223

Identifier

NCT06970223

Link

https://clinicaltrials.gov/study/NCT06970223

Phase

Phase I

Status

Recruiting

Sponsor

ViiV Healthcare

More details

This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.

Purpose

A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV

Interventions

Not provided

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-04-22 00:00:00

Anticipated Date of Last Follow-up
2025-05-05 00:00:00

Estimated Primary Completion Date
2025-07-30 00:00:00

Estimated Completion Date
2026-07-07 00:00:00

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: 1. At the time of obtaining informed consent, 18 years of age. 2. Body weight 50 kg and BMI within the range 18 to 32 kg/m2 (inclusive). 3. Participants who are overtly healthy as determined by medical evaluation by a responsible and experienced physician, including medical history, physical examination, laboratory tests and cardiac monitoring. 4. A participant with a significant clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included if the investigator determines and documents that the finding is unlikely to introduce additional

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

60

Allocation

Randomized

Intervention model

Cross-over assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Not provided

Key resources

CABNATE

Identifier

NCT07275606

Link

https://clinicaltrials.gov/study/NCT07275606

Phase

Phase I/II

Status

Not yet recruiting

Sponsor

ViiV Healthcare

More details

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of cabotegravir in neonates exposed to human immunodeficiency virus (HIV)-1.

Purpose

A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1

Interventions

Intervention 1

Intervention 2

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2026-03-17

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2025-11-27

Estimated Primary Completion Date
2029-10-10

Estimated Completion Date
2029-10-10

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Neonates

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * At least 37 weeks gestation at delivery. * \<=10 days of life. * Birth weight at least 2 kg. * At Entry, neonate has initiated standard of care Antiretroviral drug (ARV) prophylaxis. * At Entry, neonate is generally healthy as determined by the site Investigator based on review of all available medical history information and physical examination findings. * Mother is on a Dolutegravir (DTG) based regimen for a minimum of 4 weeks prior to delivery, regardless of maternal viral load. * Mother is currently breastfeeding or plans to breastfeed infant. * Mother is of legal age or circumstance to provide independent informed consent and is willing and able to provide documented informed consent for her and her infant's participation in this study. * Mother has confirmed H

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

66

Allocation

Not provided

Intervention model

Sequential assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Prevention

Key resources

219679

Identifier

NCT05776108

Link

https://clinicaltrials.gov/study/NCT05776108

Phase

Phase I

Status

Completed

Sponsor

ViiV Healthcare

More details

This study will assess the relative bioavailability of the CAB DT formulation relative to that of the CAB IR formulation and to assess the effect of food on the CAB DT formulation.

Purpose

A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-03-23

Anticipated Date of Last Follow-up
2023-12-12

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2023-06-08

Actual Completion Date
2023-06-08

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion criteria: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form (ICF). * Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and electrocardiogram). * Body weight greater than or equal to (\>=) 50.0 kilograms (kg) (110 pounds \[lbs\]) for males and \>= 45 kg (99 lbs) for females and Body mass index within the range 18.5 to 31.0 kilogram per meter square (kg/m2) (inclusive) at Screening. * Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Female: A female partici

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

24

Allocation

Randomized

Intervention model

Cross-over assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Not provided

Studied route(s) of administration

Not provided

Use case

Not provided

Key resources

Proprietary excipients used

Mannitol (E421), polysorbate 20, macrogol 3350, water for injectable preparations ad solutionem pro 1 ml.