Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen

NCT05502341 · tracked via the Priya Life Science UK tracker

Sponsor

Gilead Sciences

Phase

Phase 2/3

Started

2022-08-16

Last updated

2026-08-10

Condition(s) studied

HIV-1-infection

Investigational drug(s) / intervention(s)

BictegravirLenacapavirBIC/LEN FDCStable Baseline Regimen

Bictegravir: Tablets administered orally without regard to food

Lenacapavir: Tablets administered orally without regard to food

BIC/LEN FDC: Tablets administered orally without regard to food

Stable Baseline Regimen: SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva). * Nucleos(t)ide Reverse Transcriptase Inhibitors: * Abacavir * Emtricitabine * Lamivudine * Tenofovir alafenamide * Tenofovir disoproxil fumarate * Zidovudine * Non-Nucleosite Reverse Transcriptase Inhibitors: * Delavirdine * Efavirenz * Nevirapine * Rilpivirine * Doravirine * Integrase Inhibitors: * Bictegravir * Cabotegravir * Dolutegravir * Elvitegravir * Raltegravir * Protease Inhibitors: * Atazanavir * Darunavir * Fosamprenavir * Indinavir * Lopinavir * Nelfinavir * Saquinavir * Tipranavir * Chemokine Co-receptor 5 (CCR5) Antagonist: * Maraviroc * Fusion Inhibitors: * Enfuvirtide * gp120 Attachment Inhibitor: * Fostemsavir * Anti-CD4 Monoclonal Antibodies: * Ibalizumab-uiyk

Study summary

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Key Inclusion Criteria: * If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be \< 50 copies/mL. * At least one documented plasma HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be \< 50 copies/mL * Plasma HIV-1 RNA levels \< 50 copies/mL at screening. * Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to existing single-tablet regimens (STR), and on this regimen for at least 6 months prior to the screening visit. The criteria to define a complex regimen in this study are as follows: * A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least 1 other third agent (ie, an agent from a class other than NRTIs) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®)(BVY) + darunavir/cobicistat, BVY + etravirine), or * A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or * A regimen containing parenteral agent(s) (excluding a complete long-acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents. * No documented or suspected resistance to bictegravir (BIC). * Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy. Key Exclusion Criteria: * Prior use of, or exposure to, lenacapavir (LEN) * Active tuberculosis infection * Chronic hepatitis B virus (HBV) infection Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm — Week 24
Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm — Week 48

Trial sites (94)

Facility	City	Region
Be Well Medical Center	Berkeley	California
Pacific Oaks Medical Group	Beverly Hills	California
Ruane Clinical Research Group, Inc	Los Angeles	California
Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care	Oakland	California
Bios Clinical Research	Palm Springs	California
University of California San Diego (UCSD)	San Diego	California
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center	Torrance	California
The Men's Health Foundation	West Hollywood	California
Denver Health Medical Center	Denver	Colorado
Yale University; School of Medicine; AIDS Program	New Haven	Connecticut
Midland Florida Clinical Research Center, LLC	DeLand	Florida
Therafirst Medical Centers	Fort Lauderdale	Florida
Gary Richmond, MD, PA, Inc.	Fort Lauderdale	Florida
Midway Immunology & Research Center, LLC	Ft. Pierce	Florida
Schiff Center for liver Diseases/University of Miami	Miami	Florida
Floridian Clinical Research	Miami Lakes	Florida
Orlando Immunology Center	Orlando	Florida
Therapeutic Concepts, PA	Orlando	Florida
Triple O Research Institute PA	West Palm Beach	Florida
Atlanta ID Group	Atlanta	Georgia
Mercer University School of Medicine	Macon	Georgia
Howard Brown Health Center	Chicago	Illinois
Kansas City Care Clinic	Kansas City	Missouri
Southampton Healthcare, Inc.	St Louis	Missouri
Saint Michael's Medical Center	Newark	New Jersey
AXCES Research Group	Santa Fe	New Mexico
New York Presbyterian Hospital	Flushing	New York
Ricky K. Hsu, MD, PC	New York	New York
University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
East Carolina University	Greenville	North Carolina
Philadelphia FIGHT	Philadelphia	Pennsylvania
Medical University of South Carolina (MUSC) Research NEXUS	Charleston	South Carolina
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	Dallas	Texas
Texas Centers for Infectious Disease Associates	Fort Worth	Texas
Gordon E. Crofoot MD PA	Houston	Texas
Diagnostic Clinic of Longview - Center for Clinical Research	Longview	Texas
Peter Shalit, MD	Seattle	Washington

+ 54 more sites — see the full list on the official registry below.

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Other trials for the same condition

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 Active, not recruiting

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 Active, not recruiting

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy 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 NCT05502341 on ClinicalTrials.gov ↗ ← All trials in the UK