At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Cabotegravir Tablets, Cabotegravir Injectable Suspension (CAB LA), and 3 other interventions for HIV Infections. Completed, enrolled 687 participants across 117 sites in 14 countries.
Detailed 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.
Study Details
Timeline
Interventions
CAB tablets were available as film coated tablets for oral administration.
CAB LA was available as sterile suspension for injection in GSK1265744 for administration as IM injection.
RPV was administered as tablets for oral administration.
RPV LA was available as a sterile suspension of RPV to be administered as an IM injection.
BIK was a three-drug fixed dose combination product BIC, FTC, and TAF for oral administration.