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
NCT ID: NCT04150068
Last Updated: 2025-09-26
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
72 participants
INTERVENTIONAL
2019-11-21
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1A: Lenacapavir
Participants with HIV-1 ribonucleic acid (RNA) ≥ 400 copies/mL and with a \<0.5 log10 HIV-1 RNA decline at Cohort Selection visit compared with screening visit will receive oral lenacapavir (LEN) 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive subcutaneous (SC) LEN 927 mg and will initiate an optimized background regimen (OBR) at Day 1 SC Visit (14 days after the first dose of oral LEN).
Participants will receive their subsequent SC LEN injection at Week 26 Visit (relative to Day 1 SC). Participants will be given an option to receive SC LEN injection at Weeks 52 and 156, while continuing their OBR, until product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country.
Oral Lenacapavir
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
Cohort 1B: Placebo to Lenacapavir
Participants with HIV-1 RNA ≥ 400 copies/mL and with a \<0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit will receive oral LEN placebo on Days 1, 2, and 8 while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive oral LEN 600 mg on Days 15 and 16 and 300 mg on Day 22, and will initiate an OBR on Day 15. At Day 1 SC (14 days after the first dose of oral LEN), participants will receive SC LEN 927 mg while continuing OBR.
Participants will receive their subsequent SC LEN injection at Week 26 Visit (relative to Day 1 SC). Participants will be given an option to receive SC LEN injection at Weeks 52 and 156, while continuing their OBR, until the product becomes accessible to participants through an access program or until Gilead elects to discontinue study in the country.
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
Cohort 2: Lenacapavir
Participants with a ≥ 0.5 log10 copies/mL HIV-1 RNA decline at the Cohort Selection Visit compared with the screening visit or with HIV-1 RNA \< 400 copies/mL or if Cohort 1 is fully enrolled will receive oral LEN 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, and will initiate an OBR on Day 1 in Oral Lead-in Period (Baseline to Day 14); followed by Maintenance Period where participants will receive SC LEN 927 mg at Day 1 SC Visit (14 days after the first dose of oral LEN) while continuing their OBR.
Participants will receive their subsequent SC LEN injection at Week 26 Visit (relative to Day 1 SC). Participants will be given an option to receive SC LEN injection at Weeks 52 and 156, while continuing their OBR, until the product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country.
Oral Lenacapavir
Tablets administered without regard to food
Subcutaneous Lenacapavir
Administered in the abdomen via subcutaneous injections
Optimized Background Regimen (OBR)
Optimized background regimen as prescribed by the Investigator
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Ruane Clinical Research Group Inc
Los Angeles, California, United States
Mills Clinical Research
Los Angeles, California, United States
Eisenhower Health Center at Rimrock
Palm Springs, California, United States
One Community Health
Sacramento, California, United States
Yale University; School of Medicine
New Haven, Connecticut, United States
Washington Health Institute
Washington D.C., District of Columbia, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States
Gary J. Richmond, M.D., P.A.
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Floridian Clinical Research
Hialeah, Florida, United States
AIDS Healthcare Foundation - South Beach
Miami Beach, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
St. Joseph's Hospital Comprehensive Research Institute
Tampa, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Emory Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, United States
Atlanta ID Group, PC
Atlanta, Georgia, United States
Chatham County Health Department
Savannah, Georgia, United States
Howard Brown Health Center
Chicago, Illinois, United States
Northstar Healthcare
Chicago, Illinois, United States
Be Well Medical Center
Berkley, Michigan, United States
Southampton Healthcare, Inc.
St Louis, Missouri, United States
New York-Presbyterian/Queens
Flushing, New York, United States
North Shore University Hospital/Division of Infectious Diseases
Manhasset, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Atrium Health- Infectious Disease Consultants
Charlotte, North Carolina, United States
Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
1265 Union Avenue, 8 East
Memphis, Tennessee, United States
Central Texas Clinical Research
Austin, Texas, United States
St Hope Foundation
Bellaire, Texas, United States
AIDS Arms, Inc. DBA Prism Health North Texas
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, United States
The Crofoot Research Center, INC.
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, United States
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, Canada
Maple Leaf Research/Maple Leaf Medical Clinic
Toronto, Ontario, Canada
Clinique de médecine urbaine du Quartier Latin
Montreal, Quebec, Canada
The Ottawa Hospital
Ottawa, , Canada
Instituto Dominicano de Estudios Virologicos (IDEV)
Santo Domingo, , Dominican Republic
Hospital Dr. Salvador Bienvenido Gautier
Santo Domingo, , Dominican Republic
Hôpital Sainte-Marguerite
Marseille, , France
Hôpital Saint-Louis
Paris, , France
Hôpital Saint-Antoine
Paris, , France
Hôpital Bichat-Claude Bernard
Paris, , France
Universitätsklinikum Frankfurt, Medizinische Klinik II
Frankfurt am Main, Hesse, Germany
Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie
Essen, , Germany
ICH Study Center GmbH & Co. KG
Hamburg, , Germany
University of Naples Federico II
Bergamo, , Italy
UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1
Brescia, , Italy
Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele
Milan, , Italy
U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
Roma, , Italy
U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, , Italy
National Hospital Organization Nagoya Medical Center
Nagoya, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, , Japan
Durban International Clinical Research Site, Enhancing Care Foundation
Durban, , South Africa
Helen Joseph Hospital
Johannesburg, , South Africa
Vx Pharma
Pretoria, , South Africa
Perinatal HIV Research Unit (PHRU)
Soweto, , South Africa
Hospital Universitari Germans Trías i Pujol
Badalona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan, , Taiwan
Thai Red Cross AIDS Research Center
Bangkok, , Thailand
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, , Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, , Thailand
Faculty of Medicine, Khon Kaen University
Khon Kaen, , Thailand
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, , Thailand
Countries
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References
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Segal-Maurer S, Castagna A, Berhe M, et al. Potent Antiviral Activity of Lenacapavir in Phase 2/3 in Heavily ART-Experienced PWH [Abstract 127]. Presented at: Conference on Retroviruses and Opportunistic Infections; 2021 March 6-10.
Ogbuagu O, Molina JM, Chetchotisakd P, Ramgopal MN, Sanchez W, Brunetta J, Castelli F, Crofoot GE, Hung CC, Ronot-Bregigeon S, Margot NA, Wang H, Dvory-Sobol H, Rhee MS, Segal-Maurer S. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multidrug-Resistant HIV-1: Week 104 Results of a Phase 2/3 Trial. Clin Infect Dis. 2025 Mar 17;80(3):566-574. doi: 10.1093/cid/ciae423.
Ogbuagu O, Segal-Maurer S, Ratanasuwan W, Avihingsanon A, Brinson C, Workowski K, Antinori A, Yazdanpanah Y, Trottier B, Wang H, Margot N, Dvory-Sobol H, Rhee MS, Baeten JM, Molina JM; GS-US-200-4625 investigators. Efficacy and safety of the novel capsid inhibitor lenacapavir to treat multidrug-resistant HIV: week 52 results of a phase 2/3 trial. Lancet HIV. 2023 Aug;10(8):e497-e505. doi: 10.1016/S2352-3018(23)00113-3. Epub 2023 Jul 11.
Segal-Maurer S, DeJesus E, Stellbrink HJ, Castagna A, Richmond GJ, Sinclair GI, Siripassorn K, Ruane PJ, Berhe M, Wang H, Margot NA, Dvory-Sobol H, Hyland RH, Brainard DM, Rhee MS, Baeten JM, Molina JM; CAPELLA Study Investigators. Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2022 May 12;386(19):1793-1803. doi: 10.1056/NEJMoa2115542.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Primary Efficacy Endpoint Analysis
Document Type: Statistical Analysis Plan: Week 26 Interim Analysis
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2019-003814-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-200-4625
Identifier Type: -
Identifier Source: org_study_id
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