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

NCT05502341 | Active Not Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: GS-US-621-62892022-500929-33DOH-27-052023-8574jRCT2051230168
• Study Type: interventional
• Target: 689
• Locations: 15 countries
• Sites: 94

Brief 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).

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (12)

• 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 2: Change From Baseline in CD4 Cell Count at Week 24

  Baseline, Week 24

• Phase 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (AEs) Through Week 24

  First dose date up to Week 24

• Phase 2: Pharmacokinetic (PK) Parameter: Cmax of Bictegravir (BIC) and Lenacapavir (LEN) at Steady State

  Day 1 up to Week 24

• Phase 2: PK Parameter: AUCtau of BIC and LEN at Steady State

  Day 1 up to Week 24

Study Arms (5)

Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg

EXPERIMENTAL

Participants will switch from their stable baseline regimen (SBR) to a regimen of BIC 75 mg + LEN 25 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 25 mg starting on Day 1 up to the end of randomized treatment (ERT) visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg fixed dose combination (FDC).

Drug: Bictegravir; Drug: Lenacapavir

Phase 2: BIC 75 mg + LEN 50 mg

EXPERIMENTAL

Participants will switch from their SBR to a regimen of BIC 75 mg + LEN 50 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 50 mg starting on Day 1 up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.

Drug: Bictegravir; Drug: Lenacapavir

Phase 2: Stable Baseline Regimen (SBR)

ACTIVE COMPARATOR

Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.

Drug: Stable Baseline Regimen

Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC)

EXPERIMENTAL

Participants will switch from their SBR to a regimen of BIC/LEN 75 mg/50 mg FDC. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC/LEN 75 mg/50 mg FDC starting on Day 1 up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.

Drug: BIC/LEN FDC

Phase 3: Stable Baseline Regimen

ACTIVE COMPARATOR

Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.

Drug: Stable Baseline Regimen

Interventions

Bictegravir DRUG

Tablets administered orally without regard to food

Also known as: GS-9883

Phase 2: BIC 75 mg + LEN 50 mg; Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg

Lenacapavir DRUG

Tablets administered orally without regard to food

Also known as: GS-6207

Phase 2: BIC 75 mg + LEN 50 mg; Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg

BIC/LEN FDC DRUG

Tablets administered orally without regard to food

Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC)

Stable Baseline Regimen DRUG

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

Phase 2: Stable Baseline Regimen (SBR); Phase 3: Stable Baseline Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior use of, or exposure to, lenacapavir (LEN)
• Active tuberculosis infection
• Chronic hepatitis B virus (HBV) infection

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (94)

Be Well Medical Center

Berkeley, California, 48072, United States

Location

Pacific Oaks Medical Group

Beverly Hills, California, 90211, United States

Location

Ruane Clinical Research Group, Inc

Los Angeles, California, 90036, United States

Location

Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care

Oakland, California, 94609, United States

Location

Bios Clinical Research

Palm Springs, California, 92262, United States

Location

University of California San Diego (UCSD)

San Diego, California, 92103, United States

Location

Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center

Torrance, California, 90502, United States

Location

The Men's Health Foundation

West Hollywood, California, 90046, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Yale University; School of Medicine; AIDS Program

New Haven, Connecticut, 06510, United States

Location

Midland Florida Clinical Research Center, LLC

DeLand, Florida, 32720, United States

Location

Therafirst Medical Centers

Fort Lauderdale, Florida, 33308, United States

Location

Gary Richmond, MD, PA, Inc.

Fort Lauderdale, Florida, 33316, United States

Location

Midway Immunology & Research Center, LLC

Ft. Pierce, Florida, 34982, United States

Location

Schiff Center for liver Diseases/University of Miami

Miami, Florida, 33136, United States

Location

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Therapeutic Concepts, PA

Orlando, Florida, 32803, United States

Location

Triple O Research Institute PA

West Palm Beach, Florida, 33407, United States

Location

Atlanta ID Group

Atlanta, Georgia, 30309, United States

Location

Mercer University School of Medicine

Macon, Georgia, 31201, United States

Location

Howard Brown Health Center

Chicago, Illinois, 60613, United States

Location

Kansas City Care Clinic

Kansas City, Missouri, 64111, United States

Location

Southampton Healthcare, Inc.

St Louis, Missouri, 63139, United States

Location

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

AXCES Research Group

Santa Fe, New Mexico, 87505, United States

Location

New York Presbyterian Hospital

Flushing, New York, 11355, United States

Location

Ricky K. Hsu, MD, PC

New York, New York, 10001, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

Philadelphia FIGHT

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina (MUSC) Research NEXUS

Charleston, South Carolina, 29425, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

St. Hope Foundation

Bellaire, Texas, 77401, United States

Location

AIDS Arms, Inc., DBA Prism Health North Texas

Dallas, Texas, 75208, United States

Location

North Texas Infectious Diseases Consultants

Dallas, Texas, 75246, United States

Location

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, 76104, United States

Location

Gordon E. Crofoot MD PA

Houston, Texas, 77098, United States

Location

Diagnostic Clinic of Longview - Center for Clinical Research

Longview, Texas, 75605, United States

Location

Peter Shalit, MD

Seattle, Washington, 98104, United States

Location

Hospital General de Agudos J.M Ramon Mejia

Buenos Aires, 1072, Argentina

Location

Fundación Huésped

Buenos Aires, 1202, Argentina

Location

Helios Salud

Buenos Aires, 1425, Argentina

Location

St.Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Taylor Square Private Clinic

Darlinghurst, New South Wales, 2011, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Chronic Viral Illness Service / McGill University Health Centre (MUHC)

Decarie Montreal, H4A 3J1, Canada

Location

Clinique Medicale du Quartier Latin

Montreal, H2L 0B1, Canada

Location

The Ottawa Hospital - General Campus

Ottawa, K1H 8L6, Canada

Location

ID Clinic

Regina, S4P 0W5, Canada

Location

Maple Leaf Research

Toronto, M5G 1K2, Canada

Location

Spectrum Health

Vancouver, V6Z 2T1, Canada

Location

Instituto Dominicano de Estudio Virologicos - IDEV

Santo Domingo, Dominican Republic

Location

CHU Nice-Hôpital l'Archet

Nice, 6202, France

Location

Hospital Saint Louis

Paris, 75010, France

Location

Groupe Hospitalier Bichat Claude Bernard

Paris, 75018, France

Location

Höpital de la Pitié Salpêtrière

Paris, 75651, France

Location

zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

Berlin, 10439, Germany

Location

Universitatsklinikum Bonn

Bonn, 53127, Germany

Location

Infektio Research GmbH & Co.KG

Frankfurt, 60596, Germany

Location

ICH Study Center GmbH & Co. KG

Hamburg, 20146, Germany

Location

MVZ München am Goetheplatz

München, Germany

Location

IRCCS Ospedale San Raffaele

Milan, 20127, Italy

Location

ASST Fatebenefratelli Sacco

Milan, 20157, Italy

Location

Azienda Ospedaliero-Universitaria di Modena

Modena, 40124, Italy

Location

Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

Roma, 00149, Italy

Location

ASL Città di Torino

Torino, 10149, Italy

Location

National Hospital Organization Nagoya Medical Center

Nagoya, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, 540-0006, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Tokyo, 162-0052, Japan

Location

Hope Clinical Research

San Juan, PR, 00909, Puerto Rico

Location

Proyecto ACTU

San Juan, PR, 00935, Puerto Rico

Location

Desmond Tutu Health Foundation Clinical Trials Unit

Cape Town, 7925, South Africa

Location

Sefako Makgatho Health Sciences University

Ga-Rankuwa, 208, South Africa

Location

Ezintsha

Johannesburg, 2193, South Africa

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Yonsei University Severance Hospital

Seoul, 03722, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Hospital Clinic Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Ramon y Cajal, Madrid

Madrid, 28034, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 4103, Spain

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 81362, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 22060, Taiwan

Location

Taoyuan General Hospital

Taoyuan, 33004, Taiwan

Location

Department of HIV & Sexual Medicine

Birmingham, B9 5SS, United Kingdom

Location

Brighton and Sussex University Hospitals NHS Trust

Brighton, BN2 3EW, United Kingdom

Location

Barts Health NHS Trust

London, E1 1BB., United Kingdom

Location

HIV medicine and infectious diseases

London, SE5 9RS, United Kingdom

Location

St.Stephen's AIDS Trust, Clinical Trials Unit, 1st Floor, St.Stephen's Centre

London, SW109NH, United Kingdom

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

bictegravir; lenacapavir

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 16, 2022
• Study Start: August 16, 2022
• Primary Completion: September 29, 2025
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4); FR (4); US (40); AR (3); CA (6); KR (4); ES (5); JP (3); AU (4); IT (5); GB (5); ZA (3); DE (5); PR (2); DO (1)