Clinical trials
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
CAB LA administered IM gluteal
Intervention 2
New formulation of CAB LA (4M) administered IM gluteal
Countries
Puerto Rico
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-12-20
Anticipated Date of Last Follow-up
2025-11-14
Estimated Primary Completion Date
2026-09-09
Estimated Completion Date
2029-01-10
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
-
Children
-
Adults
-
Older Adults
Genders
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
Negative to
: HIV, HBV
Considered high risk to
:
Other health status: The study enrolled healthy adolescent and adult participants
Study type
Interventional (clinical trial)
Enrollment
229
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
Other/Variable/Unknown
:
"Once Every Four Months
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intramuscular
Use case
PrEP
Key resources
Two-to-Four
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
Drug: CAB LA (2M)
Intervention 2
Drug: CAB LA (4M formulation)
Dosage: 800 mg, 1200 mg, and 1600 mg
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-01-17
Anticipated Date of Last Follow-up
2025-06-16
Estimated Primary Completion Date
2027-03-09
Estimated Completion Date
2027-11-08
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
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
Negative to
: HIV, HBV, HCV
Considered at low risk of
: HIV
Other health status: The study enrolled healthy adults
Study type
Interventional (clinical trial)
Enrollment
69
Allocation
Non-randomized
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
Other/Variable/Unknown
:
"Once Every Four Months
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Intramuscular
Use case
PrEP
Key resources
218012
Identifier
NCT05418868
Link
https://clinicaltrials.gov/study/NCT05418868
Phase
Phase I
Status
Recruiting
Sponsor
ViiV Healthcare
More details
This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) \>=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results. Part D of the study (CAB \>=400 mg/mL with rHuPH20) will not
Purpose
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
Interventions
Intervention 1
Cabotegravir 200 mg/mL
Intervention 2
Cabotegravir >=400 mg/mL
Intervention 3
Cabotegravir Formulation I
Intervention 4
CAB Formulation J
Intervention 5
rHuPH20
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-06-14
Anticipated Date of Last Follow-up
2025-12-10
Estimated Primary Completion Date
2027-06-08
Estimated Completion Date
2027-06-08
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
* At the time of obtaining informed consent, participants age should be greater than or equal to (\>=)18 years and less than or equal to (\<=) 55 years.
* Participants who are overtly healthy as determined by 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 to \<=32 kilogram per meter square (kg/m\^2).
* Participants who are negative on a single test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction \[PCR\] laboratory or point of care test), performed on the day of admission. A negative result is required prior to the administration of study intervention on Day 1.
* C
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
214
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)
Injectable
Studied route(s) of administration
Subcutaneous
Intramuscular
Use case
Unspecified
Key resources
Not provided
