Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance

NCT04150068 · tracked via the Priya Life Science USA tracker

Sponsor

Gilead Sciences

Phase

Phase 2/3

Started

2019-11-21

Last updated

2026-03-13

Condition(s) studied

HIV-1-infection

Investigational drug(s) / intervention(s)

Oral LenacapavirOral Lenacapavir PlaceboSubcutaneous LenacapavirFailing ARV RegimenOptimized Background Regimen (OBR)

Oral Lenacapavir: Tablets administered without regard to food

Oral Lenacapavir Placebo: Tablets administered without regard to food

Subcutaneous Lenacapavir: Administered in the abdomen via subcutaneous injections

Failing ARV Regimen: Failing antiretroviral (ARV) regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen.

Optimized Background Regimen (OBR): Optimized background regimen as prescribed by the Investigator

Study summary

The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency virus type 1 (HIV-1) (PWH) with multi-drug resistance (MDR).

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

Key Inclusion Criteria: * Adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in North America and Dominican Republic) * Currently receiving a stable failing ARV regimen for \> 8 weeks * Have HIV-1 RNA ≥ 400 copies/mL at screening * Have multidrug resistance (resistance to ≥2 agents from ≥3 of the 4 main classes of ARV) * Have no more than 2 fully active ARV remaining from the 4 main classes that can be effectively combined to form a viable regimen * Able and willing to receive an OBR together with lenacapavir * No Hepatitis C virus (HCV) ongoing infection Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Percentage of Participants in Cohort 1 Achieving a Reduction of ≥ 0.5 log10 Copies/mL in Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) From Baseline to the End of Functional Monotherapy Period — Baseline up to Day 1 SC Visit (14 days after the first dose of oral lencapavir) or Day 15

Trial sites (75)

Facility	City	Region
Ruane Clinical Research Group Inc	Los Angeles	California
Mills Clinical Research	Los Angeles	California
Eisenhower Health Center at Rimrock	Palm Springs	California
One Community Health	Sacramento	California
Yale University; School of Medicine	New Haven	Connecticut
Washington Health Institute	Washington D.C.	District of Columbia
Midland Florida Clinical Research Center, LLC	DeLand	Florida
Gary J. Richmond, M.D., P.A.	Fort Lauderdale	Florida
Midway Immunology and Research Center	Ft. Pierce	Florida
Floridian Clinical Research	Hialeah	Florida
AIDS Healthcare Foundation - South Beach	Miami Beach	Florida
Orlando Immunology Center	Orlando	Florida
St. Joseph's Hospital Comprehensive Research Institute	Tampa	Florida
Triple O Research Institute, P.A.	West Palm Beach	Florida
Emory Hospital Midtown Infectious Disease Clinic	Atlanta	Georgia
Atlanta ID Group, PC	Atlanta	Georgia
Chatham County Health Department	Savannah	Georgia
Howard Brown Health Center	Chicago	Illinois
Northstar Healthcare	Chicago	Illinois
Be Well Medical Center	Berkley	Michigan
Southampton Healthcare, Inc.	St Louis	Missouri
New York-Presbyterian/Queens	Flushing	New York
North Shore University Hospital/Division of Infectious Diseases	Manhasset	New York
Jacobi Medical Center	The Bronx	New York
Atrium Health- Infectious Disease Consultants	Charlotte	North Carolina
Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
The Miriam Hospital	Providence	Rhode Island
1265 Union Avenue, 8 East	Memphis	Tennessee
Central Texas Clinical Research	Austin	Texas
St Hope Foundation	Bellaire	Texas
AIDS Arms, Inc. DBA Prism Health North Texas	Dallas	Texas
North Texas Infectious Diseases Consultants, P.A.	Dallas	Texas
The Crofoot Research Center, INC.	Houston	Texas
DCOL Center for Clinical Research	Longview	Texas
Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)	Annandale	Virginia
Vancouver ID Research and Care Centre Society	Vancouver	British Columbia
Maple Leaf Research/Maple Leaf Medical Clinic	Toronto	Ontario
Clinique de médecine urbaine du Quartier Latin	Montreal	Quebec
The Ottawa Hospital	Ottawa	Canada
Instituto Dominicano de Estudios Virologicos (IDEV)	Santo Domingo	Dominican Republic

+ 35 more sites — see the full list on the official registry below.

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Other trials for the same condition

Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children Recruiting

Long-Term Follow-Up Study of HIV-1 Infected Adults Who Received EBT-101 Enrolling by invitation

Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment Recruiting

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 Active, not recruiting

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04150068 on ClinicalTrials.gov ↗ ← All trials in the USA