Zinlirvimab (ZAB)

Associated long-acting platforms

Monoclonal antibodies and antibody drug conjugates

Administration route

Subcutaneous, Intramuscular

Therapeutic area(s)

Use case(s)

Use of drug

Dosage

Drug information

Delivery device(s)

No delivery device

Scale-up prospects

Not reported for this product. Generic mAb scale-up considerations apply: formulation stability at high concentration, pharmacokinetic suitability, and maintenance of critical quality attributes

Tentative equipment list for manufacturing

Not reported for this product.

Manufacturing

Recombinant human IgG1 lambda produced in mammalian cell culture by Gilead. Process details not published.

Specific analytical instrument required for characterization of formulation

Not reported for this product. Standard mAb characterisation applies: ion-exchange chromatography and capillary isoelectric focusing (charge variants), size-exclusion chromatography (aggregates), DSC (thermal stability), subvisible particle counting, ELISA for serum concentrations, TZM.bl neutralisation assays for susceptibility.

YCO-0946

Identifier

NCT03254277

Link

https://clinicaltrials.gov/study/NCT03254277

Phase

Phase I

Status

Completed

Sponsor

Rockefeller University

More details

Not provided

Purpose

Evaluate the safety, tolerability and pharmacokinetics of a single administration of 3BNC117-LS in HIV-uninfected and HIV-1 infected participants.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2017-09-13

Anticipated Date of Last Follow-up
2026-05-19

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2020-12-31

Actual Completion Date
2020-12-31

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

Study participants placed into groups of HIV-infected and HIV-uninfected individuals. Inclusion criteria for HIV positive groups: Males and females aged 18-65 who have documented HIV-1 infection with CD4+ T cell counts of > 300 cells/μL and currently receiving antiretroviral therapy (ART) with < 20 copies/ml plasma HIV-1 RNA or not receiving ART for a minimum of 8 weeks with < 100,000 copies/ml plasma HIV-1 RNA. Inclusion criteria for HIV negative groups: Males and females aged 18-65 who have low risk for HIV infection and agree to implement two methods of effective contraception if sexually active.

Health status

Study type

Interventional (clinical trial)

Enrollment

43

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

A5364

Identifier

NCT05079451

Link

https://clinicaltrials.gov/study/NCT05079451

Phase

Phase I

Status

Withdrawn

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

More details

Protocol Withdrawal.

Purpose

Evaluate the ability and safety of the combined bNAbs 10-1074-LS and 3BNC117-LS to prevent viral rebound during an analytical antiretroviral treatment interruption.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-01-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2023-09-06

Estimated Primary Completion Date
2024-01-15

Estimated Completion Date
2024-02-15

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

Individuals aged 18-70 years with confirmed HIV-1 infection who have received a stable suppressive antiretroviral regimen (< 50 copies/ml plasma HIV-1 RNA levels) for a minimum of 48 weeks prior to enrolment with no reported continuous interruption of a treatment greater than 7 days. CD4+ T cell counts of > 450 cells/µL with a nadir of ≥200 cells µL is required for trial eligibility.

Health status

Study type

Interventional (clinical trial)

Enrollment

Not provided

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

PAUSE

Identifier

NCT06031272

Link

https://clinicaltrials.gov/study/NCT06031272

Phase

Phase I

Status

Completed

Sponsor

AIDS Clinical Trials Group

More details

Not provided

Purpose

Evaluate the safety, antiviral activity, and immunomodulatory effects of co-administered 3BNC117-LS-J and 10-1074-LS-J in ART-treated adults in Sub-Saharan Africa.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-05-15

Actual Start Date
2024-05-28

Anticipated Date of Last Follow-up
2026-08-14

Estimated Primary Completion Date
2025-06-30

Estimated Completion Date
2026-06-30

Actual Primary Completion Date
2025-10-14

Actual Completion Date
2026-06-25

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 individuals aged 18 to 70 years with a confirmed HIV-1 infection and who have received stable suppressive ART for at least 96 weeks prior to study entry. Eligible participants must also display a CD4+ cell count of >450 cells/µL obtained within the previous 56 days and plasma HIV-1 RNA levels of <50 copies/mL for at least 96 weeks prior to study entry.

Health status

Study type

Interventional (clinical trial)

Enrollment

32

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

Treatment

Key resources

YCO-0971

Identifier

NCT03554408

Link

https://clinicaltrials.gov/study/NCT03554408

Phase

Phase I

Status

Completed

Sponsor

Rockefeller University

More details

Not provided

Purpose

Evaluate the pharmacokinetic profile, tolerability and safety of 10-1074-LS in the first clinical study administered individually or in combination with 3BNC117-LS to individuals with and without HIV.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2018-06-20

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2021-02-04

Actual Completion Date
2021-02-04

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

Study participants placed into groups of HIV-infected and HIV-uninfected individuals. Inclusion criteria for HIV positive groups: Males and females aged 18-65 who have documented HIV-1 infection and are currently receiving antiretroviral therapy with < 50 copies/ml plasma HIV-1 RNA levels and CD4+ T cell count of > 300 cells/μL. Inclusion criteria for HIV negative groups: Males and females aged 18-65 who have low risk for HIV infection and agree to implement two methods of effective contraception if sexually active.

Health status

Study type

Interventional (clinical trial)

Enrollment

77

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

Treatment

Key resources

MCA-0994

Identifier

NCT04250636

Link

https://clinicaltrials.gov/study/NCT04250636

Phase

Phase I

Status

Completed

Sponsor

Rockefeller University

More details

Not provided

Purpose

Evaluate the antiviral activity, pharmacokinetics and safety of single intravenous infusions of the bNAbs 3BNC117-LS and 10-1074-LS in HIV-infected individuals who are not currently receiving ART.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-10-13

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2022-01-21

Actual Completion Date
2022-02-11

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

Study participants are individuals with HIV-1 infection who have not received antiretroviral therapy (either by choice, intolerance or ART-naïvety) for at least 28 days prior to study enrolment with plasma HIV-1 RNA levels between 500 - 100,000 copies/mL and CD4+ T cell counts > 300 cells/μl.

Health status

Study type

Interventional (clinical trial)

Enrollment

6

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

GS-US-536-5939

Identifier

NCT05729568

Link

https://clinicaltrials.gov/study/NCT05729568

Phase

Phase II

Status

Active, not recruiting

Sponsor

Gilead Sciences

More details

The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (TAB; GS-5423) and zinlirvimab (ZAB; GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection. The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, TAB and ZAB, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.

Purpose

A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 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
2023-05-15

Anticipated Date of Last Follow-up
2025-06-26

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2029-12-01

Actual Primary Completion Date
2024-07-02

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

Key Inclusion Criteria: * On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit 2. A change in ART regimen ≥ 28 days prior to screening visit 2 for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed. * No clinically significant documented historical resistance to the current ART regimen with the exception of isolated nucleoside reverse transcriptase inhibitor mutations including M184V or ≤ 2 thymidine analog mutations (TAMs: M41L, D67N, K70R, L210W, T215Y, and/or K219Q). * Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL at screening visit 2. * Doc

Health status

Study type

Interventional (clinical trial)

Enrollment

83

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

GS-US-536-5938

Identifier

NCT07682961

Link

https://clinicaltrials.gov/study/NCT07682961

Phase

Phase III

Status

Not yet recruiting

Sponsor

Gilead Sciences

More details

The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment. The primary objective of this study are to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.

Purpose

Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2026-07-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2026-06-26

Estimated Primary Completion Date
2029-03-01

Estimated Completion Date
2033-03-01

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

Key Inclusion Criteria: * Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria: 1\) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at screening. * At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be \< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). A single virologic elevation of ≥ 50 copies/mL and \< 400 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable if the subsequent plasma HIV-1 RNA level is \< 50 copies/mL. * A plasma HIV-1

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

590

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

GS-US-536-5816

Identifier

NCT04811040

Link

https://clinicaltrials.gov/ct2/show/NCT04811040

Phase

Phase I

Status

Completed

Sponsor

Gilead Sciences

More details

Not provided

Purpose

Evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) teropavimab (formerly GS-5423) and GS-2872 in combination with the HIV capsid inhibitor lenacapavir

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-04-08

Anticipated Date of Last Follow-up
2024-12-19

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2022-06-09

Actual Completion Date
2023-10-26

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

On first-line antiretroviral therapy (ART) for ≥ 2 years prior to screening. A change in ART regimen ≥ 28 days prior to screening for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed.

Health status

Study type

Interventional (clinical trial)

Enrollment

32

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Double (Participant, Investigator). Clinical pharmacologist and sponsor are not masked to treatment assignment.

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

MCA-1031

Identifier

NCT05245292

Link

https://clinicaltrials.gov/study/NCT05245292

Phase

Phase I

Status

Completed

Sponsor

Rockefeller University

More details

Not provided

Purpose

Evaluate the antiretroviral activity and safety of the broadly neutralising antibodies 3BNC117-LS and 10-1074-LS in combination with IL-15 superagonist complex N-803.

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-12-07

Anticipated Date of Last Follow-up
2026-03-30

Estimated Primary Completion Date
2025-12-31

Estimated Completion Date
2025-12-31

Actual Primary Completion Date
2025-12-09

Actual Completion Date
2025-12-31

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

Study participants are males and females aged 18-70 with a confirmed HIV-1 infection who are currently receiving a stable antiretroviral treatment regimen (< 50 copies/ml plasma HIV-1 RNA) for at least 48 weeks with no reported continuous interruption of treatment greater than 7 days. CD4+ T cell counts were required to be > 450 cells/μL at enrolment with a cell count nadir of ≥ 200 cells/μL and HIV-1 RNA plasma levels at < 20 copies/ml.

Health status

Study type

Interventional (clinical trial)

Enrollment

28

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

NCT05612178

Identifier

NCT05612178

Link

https://clinicaltrials.gov/study/NCT05612178

Phase

Phase I

Status

Active, not recruiting

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

More details

Not provided

Purpose

Evaluate the safety and effects of repeated doses of 3BNC117-LS and 10-1074-LS on persistent viral reservoirs in people living with HIV who are currently receiving suppressive antiretroviral therapy.

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-07-26

Anticipated Date of Last Follow-up
2026-06-03

Estimated Primary Completion Date
2027-03-31

Estimated Completion Date
2027-03-31

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

Adult persons of any sex or gender, aged 18 years to 70; with confirmed HIV-1 infection and receiving antiretroviral therapy with plasma HIV-1 RNA levels of < 50 copies/mL and no reported interruption of ART for 7 consecutive days or longer for at least 96 weeks.

Health status

Study type

Interventional (clinical trial)

Enrollment

105

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Triple-blind masking

Masking description

Triple (Participant, Care Provider, Investigator)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

RIO

Identifier

NCT04319367

Link

https://clinicaltrials.gov/study/NCT04319367

Phase

Phase II

Status

Recruiting

Sponsor

Imperial College London

More details

Not provided

Purpose

Evaluate whether the combination of 3BNC117-LS and 10-1074-LS can prevent HIV viral rebound after discontinuing early-initiation antiretroviral treatment in adults during primary HIV infection.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-05-17

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

Estimated Primary Completion Date
2027-07-31

Estimated Completion Date
2027-07-31

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
No

Comments about the studied populations

Individuals aged 18-60 who are currently receiving a stable antiretroviral therapy (ART) regimen resulting in an undetectable HIV viral load for a time period of at least one year, which commenced within three months of documented primary HIV infection. Current CD+ T cell counts > 500 cells/µL with a nadir of CD4+ > 350 cells/µL are required. Study participants were required to be vaccinated against COVID-19 at least 28 days before enrolment.

Health status

Study type

Interventional (clinical trial)

Enrollment

72

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Triple-blind masking

Masking description

Triple (Participant, Investigator, Outcomes Assessor)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

RHIVIERA-02

Identifier

NCT05300035

Link

https://clinicaltrials.gov/study/NCT05300035

Phase

Phase II

Status

Recruiting

Sponsor

ANRS, Emerging Infectious Diseases

More details

Not provided

Purpose

Evaluate the efficacy of an intervention consisting of the long-acting broadly neutralising antibodies 3BNC117-LS and 10-1074-LS + ART in reducing HIV-1 replication during primary HIV-1 infection.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-04-11

Anticipated Date of Last Follow-up
2024-12-23

Estimated Primary Completion Date
2026-12-10

Estimated Completion Date
2028-12-10

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

Study participants are individuals with confirmed HIV-1 infection aged 18-70 at screening and no prior history of hypersensitivity or contraindication to 10-1074-LS or 3BNC117-LS intravenous infusions.

Health status

Study type

Interventional (clinical trial)

Enrollment

69

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Triple-blind masking

Masking description

Triple (Participant, Care Provider, Investigator)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

IAVI C100

Identifier

NCT04173819

Link

https://clinicaltrials.gov/study/NCT04173819

Phase

Phase I/II

Status

Completed

Sponsor

International AIDS Vaccine Initiative

More details

Not provided

Purpose

Evaluate the safety and pharmacokinetics of the combination broadly neutralizing antibodies, 3BNC117-LS-J and 10-1074-LS-J, in healthy American and African Adults.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-01-25

Anticipated Date of Last Follow-up
2025-05-02

Estimated Primary Completion Date
2023-09-01

Estimated Completion Date
2023-09-01

Actual Primary Completion Date
2023-09-01

Actual Completion Date
2023-09-01

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Healthy male and female individuals aged between 18-45 who are willing to undergo HIV testing, risk reduction counselling and receive HIV test results; in addition to maintaining low-risk behaviour for the entire trial duration.

Health status

Study type

Interventional (clinical trial)

Enrollment

225

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

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

There are either no relevant patents or these were not yet submitted to LAPaL

Publications

There are no publication

Additional documents

No documents were uploaded

Useful links

• Mponponsuo K, McMahon JH, Gorgos L, Morales-Ramirez J, Workowski K, Brunetta J, Ogbuagu O, Collins SE, VanderVeen LA, Huang H, Baeten JM, Eron JJ. Efficacy and Safety of Lenacapavir, Teropavimab, and

• Positive Proof-of-Concept Data for Investigational Combination Regimen of Lenacapavir with Broadly Neutralizing Antibodies as a Potential Twice-Yearly Approach for the Treatment of HIV

• Gilead Presents New HIV Treatment and Cure Research Data at CROI 2025, Including an Investigational Long-Acting, Twice-Yearly Therapy Option