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
CAPELLA
A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance
2 other identifiers
interventional
72
11 countries
75
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2019
Longer than P75 for phase_2
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
November 4, 2019
CompletedStudy Start
First participant enrolled
November 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2020
CompletedResults Posted
Study results publicly available
October 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
ExpectedMarch 13, 2026
February 1, 2026
11 months
October 28, 2019
September 28, 2021
February 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm
Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm
Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm
Week 52 (52 weeks after first dose of subcutaneous lenacapavir)
Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm
Week 52 (52 weeks after first dose of subcutaneous lenacapavir)
Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm
Week 104 (104 weeks after first dose of subcutaneous lenacapavir)
- +3 more secondary outcomes
Study Arms (3)
Cohort 1A: Lenacapavir
EXPERIMENTALParticipants 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 the 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). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), 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.
Cohort 1B: Placebo to Lenacapavir
PLACEBO COMPARATORParticipants 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 the 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. At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), 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.
Cohort 2: Lenacapavir
EXPERIMENTALParticipants 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. At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), 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.
Interventions
Tablets administered without regard to food
Tablets administered without regard to food
Administered in the abdomen via subcutaneous injections
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 as prescribed by the Investigator
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (75)
Ruane Clinical Research Group Inc
Los Angeles, California, 90036, United States
Mills Clinical Research
Los Angeles, California, 90069, United States
Eisenhower Health Center at Rimrock
Palm Springs, California, 92264, United States
One Community Health
Sacramento, California, 95817, United States
Yale University; School of Medicine
New Haven, Connecticut, 06510, United States
Washington Health Institute
Washington D.C., District of Columbia, 20017, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 32720, United States
Gary J. Richmond, M.D., P.A.
Fort Lauderdale, Florida, 33316, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982, United States
Floridian Clinical Research
Hialeah, Florida, 33016, United States
AIDS Healthcare Foundation - South Beach
Miami Beach, Florida, 33139, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
St. Joseph's Hospital Comprehensive Research Institute
Tampa, Florida, 33614, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, 33401, United States
Emory Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, 30308, United States
Atlanta ID Group, PC
Atlanta, Georgia, 30309, United States
Chatham County Health Department
Savannah, Georgia, 31401, United States
Howard Brown Health Center
Chicago, Illinois, 60613, United States
Northstar Healthcare
Chicago, Illinois, 60657, United States
Be Well Medical Center
Berkley, Michigan, 48072, United States
Southampton Healthcare, Inc.
St Louis, Missouri, 63139, United States
New York-Presbyterian/Queens
Flushing, New York, 11355, United States
North Shore University Hospital/Division of Infectious Diseases
Manhasset, New York, 11030, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Atrium Health- Infectious Disease Consultants
Charlotte, North Carolina, 28209, United States
Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
1265 Union Avenue, 8 East
Memphis, Tennessee, 38163, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
St Hope Foundation
Bellaire, Texas, 77401, United States
AIDS Arms, Inc. DBA Prism Health North Texas
Dallas, Texas, 75215, United States
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, 75246, United States
The Crofoot Research Center, INC.
Houston, Texas, 77098, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, 22003, United States
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, V6Z 2C9, Canada
Maple Leaf Research/Maple Leaf Medical Clinic
Toronto, Ontario, M5G 1K2, Canada
Clinique de médecine urbaine du Quartier Latin
Montreal, Quebec, H2L 4E9, Canada
The Ottawa Hospital
Ottawa, K1H 8L6, Canada
Instituto Dominicano de Estudios Virologicos (IDEV)
Santo Domingo, 10103, Dominican Republic
Hospital Dr. Salvador Bienvenido Gautier
Santo Domingo, 10514, Dominican Republic
Hôpital Sainte-Marguerite
Marseille, 13009, France
Hôpital Saint-Louis
Paris, 75010, France
Hôpital Saint-Antoine
Paris, 75012, France
Hôpital Bichat-Claude Bernard
Paris, 75018, France
Universitätsklinikum Frankfurt, Medizinische Klinik II
Frankfurt am Main, Hesse, 60590, Germany
Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie
Essen, 45122, Germany
ICH Study Center GmbH & Co. KG
Hamburg, 20146, Germany
University of Naples Federico II
Bergamo, 24127, Italy
UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1
Brescia, 25100, Italy
Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele
Milan, 20127, Italy
U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
Roma, 00149, Italy
U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168, Italy
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
Tokyo Medical University Hospital
Tokyo, 1600023, Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, 1628655, Japan
Durban International Clinical Research Site, Enhancing Care Foundation
Durban, 4302, South Africa
Helen Joseph Hospital
Johannesburg, 2092, South Africa
Vx Pharma
Pretoria, 87, South Africa
Perinatal HIV Research Unit (PHRU)
Soweto, 2013, South Africa
Hospital Universitari Germans Trías i Pujol
Badalona, 08916, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Far Eastern Memorial Hospital
New Taipei City, 22060, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan, 33004, Taiwan
Thai Red Cross AIDS Research Center
Bangkok, 10330, Thailand
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, 10400, Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700, Thailand
Faculty of Medicine, Khon Kaen University
Khon Kaen, 40002, Thailand
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, 11000, Thailand
Related Publications (21)
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.
BACKGROUNDOgbuagu O, Ratanasuwan W, Avihingsanon A, Chetchotisakd P, Wiznia A, Kimberly W, et al. Lenacapavir Efficacy in CAPELLA Patients with No Fully Active Agents in Optimized Background Regimen. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI), 2024 March 3-6
BACKGROUNDMargot N, Pennetzdorfer N, Naik V, Rhee M, Callebaut C. Cross-resistance to entry inhibitors and lenacapavir resistance through Week 52 in study CAPELLA. Antivir Ther. 2023 Dec;28(6):13596535231220754. doi: 10.1177/13596535231220754.
PMID: 38085652BACKGROUNDCastagna A, Blanco Arevalo JL, Molina JM, Antinori A, Castelli F, Yazdanpanah Y, et al. Follow-Up of Injection Site Reactions in Clinical Studies of People Using Lenacapavir Every 6 Months for HIV Treatment [Poster eP.A.104]. Presented at: European AIDS Conference (EACS), 2023 October 18-21
BACKGROUNDMargot N, Jogiraju V, VanderVeen L, Naik V, Dvory-Sobol H, Rhee MS, et al. Resistance Analysis of Long-Acting Lenacapavir in Heavily Treatment-Experienced People with HIV after 104 Weeks of Treatment [PS8 O4]. Presented at: European AIDS Conference (EACS), 2023 18-21 October
BACKGROUNDOgbuagu O, DeJesus E, Berhe M, Richmond GJ, Ruane PJ, Sinclair GI, et al. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multi-Drug Resistant HIV: Week 104 Results [Poster 1596]. Presented at: IDWeek, 2023 11-15 October
BACKGROUNDOgbuagu 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.
PMID: 37451297BACKGROUNDOgbuagu O, Avihingsanon A, Segal-Maurer S, Wang H, Rhee MS, Dvory-Sobol H, et al. Lenacapavir Oral Bridging (300 mg QW) Maintains Efficacy with a Similar Safety Profile When SC LEN Cannot Be Administered [Oral OAB0205] Presented at:12th International AIDS Society (IAS) Conference on HIV Science, 2023 23-26 July.
BACKGROUNDMargot NA, Naik V, VanderVeen L, Anoshchenko O, Singh R, Dvory-Sobol H, Rhee MS, Callebaut C. Resistance Analyses in Highly Treatment-Experienced People With Human Immunodeficiency Virus (HIV) Treated With the Novel Capsid HIV Inhibitor Lenacapavir. J Infect Dis. 2022 Nov 28;226(11):1985-1991. doi: 10.1093/infdis/jiac364.
PMID: 36082606BACKGROUNDAntinori A, Castelli F, Ronot-Bregigeon S, Yazdanpanah Y, Safran R, S. Berger DS, et al. Common Adverse Events in Clinical Studies of People Using Lenacapavir for HIV Treatment [P027]. Presented at: HIV Glasgow 2022, October 23-26
BACKGROUNDOgbuagu O, Segal-Maurer S, Ratanasuwan W, Trottier B,4 Brunetta J, Shirasaka T, et al. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People With Multi-Drug Resistant HIV: Week 52 Results [Oral 1585]. Presented at: IDWeek 2022, October 19-23
BACKGROUNDCastagna A, J Blanco JL, Hung CC, Rassool M, Ramgopal MN, Sanchez W, et al. Week 52 Subgroup Efficacy Analyses of Long-Acting Subcutaneous Lenacapavir in Phase 2/3 in Heavily Treatment-Experienced People With Multidrug-Resistant HIV (CAPELLA Study) [P026]. Presented at: HIV Glasgow, 2022 October 23-26
BACKGROUNDKumar P, Gupta S, Segal-Maurer S, Ogbuagu O, McDonald C, Brinson C, et al. Injection-Site Reaction Experience in Clinical Studies of People Using Lenacapavir For HIV Treatment [Poster EPB184]. Presented at: AIDS, 2022 29 July-2 August
BACKGROUNDSegal-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.
PMID: 35544387BACKGROUNDMargot N, Laurie VanderVeen L, Naik V, Chang S, Parvangada PC, Martin R, et al. Resistance Analysis of Long-Acting Lenacapavir in Highly Treatment-Experienced People with HIV After 26 Weeks of Treatment [Oral OS1/1]. Presented at: European AIDS Conference (EACS); 2021 October 27-30
BACKGROUNDStellbrink HJ, DeJesus E, Segal-Maurer S, Castagna A, Avihingsanon A, Blanco Arevalo JL, et al. Subgroups Efficacy Analyses of Long-Acting Subcutaneous Lenacapavir in Phase 2/3 in Heavily Treatment-Experienced People with HIV (CAPELLA study) [Abstract PE2/69]. Presented at: European AIDS Conference (EACS); 2021 October 27-30
BACKGROUNDSegal-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
BACKGROUNDOgbuagu O, Wiznia A, McGowan JP, Berger DS, Creticos CM, Hagins D, Hodge T, Osiyemi O, Sims J, Wheeler DA, Wang H, Margot NA, Dvory-Sobol H, Rhee MS, Segal-Maurer S, Molina JM. Subcutaneous Lenacapavir in People With Multidrug-Resistant HIV-1: 156 Week Results of the CAPELLA Study. Open Forum Infect Dis. 2025 Dec 19;13(1):ofaf763. doi: 10.1093/ofid/ofaf763. eCollection 2026 Jan.
PMID: 41459297BACKGROUNDMargot NA, Jogiraju V, Pennetzdorfer N, Naik V, VanderVeen LA, Ling J, Singh R, Dvory-Sobol H, Ogbuagu O, Segal-Maurer S, Molina JM, Rhee MS, Callebaut C. Resistance Analyses in Heavily Treatment-Experienced People With HIV Treated With the Novel HIV Capsid Inhibitor Lenacapavir After 2 Years. J Infect Dis. 2025 Jun 2;231(5):1239-1245. doi: 10.1093/infdis/jiaf050.
PMID: 39873394BACKGROUNDOgbuagu OE, Avihingsanon A, Segal-Maurer S, Wang H, Jogiraju VK, Singh R, Rhee MS, Dvory-Sobol H, Sklar PA, Molina JM. Efficacy, safety, and pharmacokinetics of lenacapavir oral bridging when subcutaneous lenacapavir cannot be administered. AIDS. 2025 May 1;39(6):639-648. doi: 10.1097/QAD.0000000000004142. Epub 2025 Feb 10.
PMID: 39912752BACKGROUNDOgbuagu 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.
PMID: 39206943BACKGROUND
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2019
First Posted
November 4, 2019
Study Start
November 21, 2019
Primary Completion
October 5, 2020
Study Completion (Estimated)
January 1, 2027
Last Updated
March 13, 2026
Results First Posted
October 20, 2021
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share