Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: HIV-1-infection
In brief
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.
Key facts
- Study ID
- NCT06630286
- Run by
- Gilead Sciences
- People needed
- 609
- Starts
- 2024-10-09
- Expected to finish
- 2030-08-01
- Last updated by the study team
- 2026-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Pueblo Family Physicians — Phoenix, Arizona, United States
- Kaiser Permanente Southern California — Los Angeles, California, United States
- Ruane Clinical Research Group, Inc — Los Angeles, California, United States
- Mills Clinical Research — Los Angeles, California, United States
- BIOS Clinical Research — Palm Springs, California, United States
- Optimus Medical Group — San Francisco, California, United States
- Vivent Health — Denver, Colorado, United States
- University of Colorado- Anschutz Medical Campus - PPDS — Denver, Colorado, United States
- Yale University — New Haven, Connecticut, United States
- Georgetown University — Washington D.C., District of Columbia, United States
- Whitman-Walker Health — Washington D.C., District of Columbia, United States
- CAN Community Health — Fort Lauderdale, Florida, United States
- Midway Immunology and Research Center — Ft. Pierce, Florida, United States
- CAN Community Health — Miami Gardens, Florida, United States
- Midland Research Group, Inc. — Oakland Park, Florida, United States
- Orlando Immunology Center — Orlando, Florida, United States
- AHF (AIDS Healthcare Foundation) - Pensacola Research — Pensacola, Florida, United States
- CAN Community Health — Sarasota, Florida, United States
- St. Josephs Comprehensive Research Institute — Tampa, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Infectious Disease Specialists of Atlanta — Decatur, Georgia, United States
- Mercer University — Macon, Georgia, United States
- Chatham CARE Center — Savannah, Georgia, United States
- Howard Brown Health — Chicago, Illinois, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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