Trials / Completed
CompletedNCT04542070
A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed
A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 687 (actual)
- Sponsor
- ViiV Healthcare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cabotegravir Tablets | CAB tablets were available as film coated tablets for oral administration. |
| DRUG | Cabotegravir Injectable Suspension (CAB LA) | CAB LA was available as sterile suspension for injection in GSK1265744 for administration as IM injection. |
| DRUG | Rilpivirine Tablets | RPV was administered as tablets for oral administration. |
| DRUG | Rilpivirine Injectable Suspension (RPV LA) | RPV LA was available as a sterile suspension of RPV to be administered as an IM injection. |
| DRUG | BIKTARVY Tablets (BIK) | BIK was a three-drug fixed dose combination product BIC, FTC, and TAF for oral administration. |
Timeline
- Start date
- 2020-11-09
- Primary completion
- 2022-07-13
- Completion
- 2023-04-17
- First posted
- 2020-09-09
- Last updated
- 2024-06-04
- Results posted
- 2023-09-13
Locations
117 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04542070. Inclusion in this directory is not an endorsement.