Last reviewed · How we verify
Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1 (ARTISTRY-2)
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.
Details
| Lead sponsor | Gilead Sciences |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 577 |
| Start date | 2024-03-25 |
| Completion | 2029-12 |
Conditions
- HIV-1-infection
Interventions
- Bictegravir
- Lenacapavir
- B/F/TAF
- Placebo to match B/F/TAF
- Placebo to match BIC/LEN
Primary outcomes
- Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm — Week 48
Countries
United States, Argentina, Australia, Canada, Dominican Republic, Germany, Italy, Japan, Mexico, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom