Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (NCT06630299)
A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham(UAB) 1917 Research Clinic — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (100 Sites)
Showing the first 25 of 100 sites.
- University of Alabama at Birmingham(UAB) 1917 Research Clinic — Birmingham, Alabama
- Pueblo Family Physicians — Phoenix, Arizona
- Vv-Tmf-5366229 — Los Angeles, California
- Ruane Clinical Research Group — Los Angeles, California
- BIOS Clinical Research — Palm Springs, California
- Vivent Health — Denver, Colorado
- University of Colorado Clinical and Translational Research Center — Denver, Colorado
- Yale University; School of Medicine; AIDS Program — New Haven, Connecticut
- Georgetown University Medical Center — Washington D.C., District of Columbia
- Aids Healthcare Foundation - Northpoint — Fort Lauderdale, Florida
- Midway Immunology and Research Center — Ft. Pierce, Florida
- CAN Community Health — Miami Gardens, Florida
- Orlando Immunology Center — Orlando, Florida
- AHF Pensacola — Pensacola, Florida
- CAN Community Health — Sarasota, Florida
- BayCare Health System, Inc./St. Joseph's Hospital — Tampa, Florida
- Triple O Research Institute, P.A. — West Palm Beach, Florida
- Metro Infectious Disease Consultants, P.L.L.C. — Decatur, Georgia
- Mercer University, Department of Internal Medicine — Macon, Georgia
- Chatham County Health Department — Savannah, Georgia
- Howard Brown Health Center — Chicago, Illinois
- Indiana CTSI Clinical Research Center — Indianapolis, Indiana
- Brigham and Womens's Hospital — Boston, Massachusetts
- Boston Medical Center — Boston, Massachusetts
- Community Research Initiative of New England d/b/a Community Resource Initiative (CRI) — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in HIV-1-Infection
- Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 — Washington D.C., District of Columbia
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen — Berkeley, California
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 — Birmingham, Alabama
- Impact of HIV-1 and Aging on Mucosal Vaccine Responses — Aurora, Colorado
- Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed — Birmingham, Alabama
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy — Phoenix, Arizona
Explore by condition: All HIV-1-Infection clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.