Trials / Active Not Recruiting
Active Not RecruitingNCT06741397
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)
A Phase 2b 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
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 229 (actual)
- Sponsor
- ViiV Healthcare · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Accepted
Summary
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CAB LA | Injections administered IM gluteal. |
| DRUG | New formulation of CAB LA | Injections administered IM gluteal. |
Timeline
- Start date
- 2024-12-20
- Primary completion
- 2026-09-09
- Completion
- 2029-01-10
- First posted
- 2024-12-19
- Last updated
- 2025-11-18
Locations
27 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06741397. Inclusion in this directory is not an endorsement.