Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
Summary
The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening. The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.
Timeline
- Start
- 2024-10-09
- Primary completion
- 2026-04-17
- Completion
- 2030-08
Outcome
Met primary endpoint
release “Results from ISLEND-1 Week 48 results showed that the once-weekly single tablet regimen of ISL/LEN was noninferior to BIKTARVY in maintaining virologic suppression;” gilead.com ↗
release “primary efficacy endpoint at Week 48 was met in both the Phase 3 ISLEND-1 and ISLEND-2 trials” gilead.com ↗
release “Results from ISLEND-1 Week 48 results showed that the once-weekly single tablet regimen of ISL/LEN was noninferior to BIKTARVY in maintaining virologic suppression” gilead.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bictegravir | Small molecule | 50 mg | Oral |
| Subject | Islatravir | Other / unclassified | — | Oral |
| Subject | Lenacapavir | Small molecule | — | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | Oral |