Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
Running, not enrolling · Phase 3
Conditions studied: HIV-1-Infection
In brief
The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs). The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48.
Key facts
- Study ID
- NCT06630299
- Run by
- Gilead Sciences
- People needed
- 600
- Starts
- 2024-10-08
- Expected to finish
- 2030-08-01
- Last updated by the study team
- 2026-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Pueblo Family Physicians — Phoenix, Arizona, United States
- Vv-Tmf-5366229 — Los Angeles, California, United States
- Ruane Clinical Research Group — Los Angeles, California, United States
- BIOS Clinical Research — Palm Springs, California, United States
- Vivent Health — Denver, Colorado, United States
- University of Colorado Clinical and Translational Research Center — Denver, Colorado, United States
- Yale University; School of Medicine; AIDS Program — New Haven, Connecticut, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Aids Healthcare Foundation - Northpoint — Fort Lauderdale, Florida, United States
- Midway Immunology and Research Center — Ft. Pierce, Florida, United States
- CAN Community Health — Miami Gardens, Florida, United States
- Orlando Immunology Center — Orlando, Florida, United States
- AHF Pensacola — Pensacola, Florida, United States
- CAN Community Health — Sarasota, Florida, United States
- BayCare Health System, Inc./St. Joseph's Hospital — Tampa, Florida, United States
- Triple O Research Institute, P.A. — West Palm Beach, Florida, United States
- Metro Infectious Disease Consultants, P.L.L.C. — Decatur, Georgia, United States
- Mercer University, Department of Internal Medicine — Macon, Georgia, United States
- Chatham County Health Department — Savannah, Georgia, United States
- Howard Brown Health Center — Chicago, Illinois, United States
- Indiana CTSI Clinical Research Center — Indianapolis, Indiana, United States
- Brigham and Womens's Hospital — Boston, Massachusetts, United States
- Boston Medical Center — Boston, Massachusetts, United States
- Community Research Initiative of New England d/b/a Community Resource Initiative (CRI) — Boston, Massachusetts, United States
- University of Alabama at Birmingham(UAB) 1917 Research Clinic — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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