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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: Oral Lenacapavir; Drug: Subcutaneous Lenacapavir; Drug: Failing ARV Regimen; Drug: Optimized Background Regimen (OBR); Drug: Oral Lenacapavir Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ottawa, Canada, K1H 8L6
    • The Ottawa Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2C9
      • Vancouver ID Research and Care Centre Society
  • Ontario
    • Toronto, Ontario, Canada, M5G 1K2
      • Maple Leaf Research/Maple Leaf Medical Clinic
  • Quebec
    • Montreal, Quebec, Canada, H2L 4E9
      • Clinique de médecine Urbaine du Quartier Latin
• Dominican Republic
  • Santo Domingo, Dominican Republic, 10103
    • Instituto Dominicano de Estudios Virologicos (IDEV)
  • Santo Domingo, Dominican Republic, 10514
    • Hospital Dr. Salvador Bienvenido Gautier
• France
  • Marseille, France, 13009
    • Hôpital Sainte-Marguerite
  • Paris, France, 75012
    • Hopital Saint-Antoine
  • Paris, France, 75018
    • Hopital Bichat-Claude Bernard
  • Paris, France, 75010
    • Hopital Saint-Louis
• Germany
  • Essen, Germany, 45122
    • Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie
  • Hamburg, Germany, 20146
    • ICH Study Center GmbH & Co. KG
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Universitätsklinikum Frankfurt, Medizinische Klinik II
• Italy
  • Bergamo, Italy, 24127
    • University of Naples Federico II
  • Brescia, Italy, 25100
    • UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1
  • Milan, Italy, 20127
    • Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele
  • Roma, Italy, 00149
    • U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
  • Rome, Italy, 00168
    • U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS
• Japan
  • Nagoya, Japan, 460-0001
    • National Hospital Organization Nagoya Medical Center
  • Osaka, Japan, 540-0006
    • National Hospital Organization Osaka National Hospital
  • Tokyo, Japan, 1600023
    • Tokyo Medical University Hospital
  • Tokyo, Japan, 1628655
    • Center Hospital of the National Center for Global Health and Medicine
• South Africa
  • Durban, South Africa, 4302
    • Durban International Clinical Research Site, Enhancing Care Foundation
  • Johannesburg, South Africa, 2092
    • Helen Joseph Hospital
  • Pretoria, South Africa, 87
    • Vx Pharma
  • Soweto, South Africa, 2013
    • Perinatal HIV Research Unit (PHRU)
• Spain
  • Badalona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
• Taiwan
  • Kaohsiung City, Taiwan, 81362
    • Kaohsiung Veterans General Hospital
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • New Taipei City, Taiwan, 22060
    • Far Eastern Memorial Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 33004
    • Taoyuan General Hospital, Ministry of Health and Welfare
• Thailand
  • Bangkok, Thailand, 10700
    • Faculty of Medicine Siriraj Hospital, Mahidol University
  • Bangkok, Thailand, 10400
    • Faculty of Medicine Ramathibodi Hospital, Mahidol University
  • Bangkok, Thailand, 10330
    • Thai Red Cross AIDS Research Center
  • Khon Kaen, Thailand, 40002
    • Faculty Of Medicine, Khon Kaen University
  • Nonthaburi, Thailand, 11000
    • Bamrasnaradura Infectious Diseases Institute
• United States
  • California
    • Los Angeles, California, United States, 90036
      • Ruane Clinical Research Group Inc
    • Los Angeles, California, United States, 90069
      • Mills Clinical Research
    • Palm Springs, California, United States, 92264
      • Eisenhower Health Center at Rimrock
    • Sacramento, California, United States, 95817
      • One Community Health
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University; School of Medicine
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20017
      • Washington Health Institute
  • Florida
    • DeLand, Florida, United States, 32720
      • Midland Florida Clinical Research Center, LLC
    • Fort Lauderdale, Florida, United States, 33316
      • Gary J. Richmond, M.D., P.A.
    • Ft. Pierce, Florida, United States, 34982
      • Midway Immunology and Research Center
    • Hialeah, Florida, United States, 33016
      • Floridian Clinical Research
    • Miami Beach, Florida, United States, 33139
      • AIDS Healthcare Foundation - South Beach
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center
    • Tampa, Florida, United States, 33614
      • St. Joseph's Hospital Comprehensive Research Institute
    • West Palm Beach, Florida, United States, 33401
      • Triple O Research Institute, P.A.
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Atlanta ID Group, PC
    • Atlanta, Georgia, United States, 30308
      • Emory Hospital Midtown Infectious Disease Clinic
    • Savannah, Georgia, United States, 31401
      • Chatham County Health Department
  • Illinois
    • Chicago, Illinois, United States, 60613
      • Howard Brown Health Center
    • Chicago, Illinois, United States, 60657
      • Northstar Healthcare
  • Michigan
    • Berkley, Michigan, United States, 48072
      • Be Well Medical Center
  • Missouri
    • St Louis, Missouri, United States, 63139
      • Southampton Healthcare, Inc.
  • New York
    • Flushing, New York, United States, 11355
      • New York-Presbyterian/Queens
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital/Division of Infectious Diseases
    • The Bronx, New York, United States, 10461
      • Jacobi Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Atrium Health- Infectious Disease Consultants
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • 1265 Union Avenue, 8 East
  • Texas
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research
    • Bellaire, Texas, United States, 77401
      • St Hope Foundation
    • Dallas, Texas, United States, 75246
      • North Texas Infectious Diseases Consultants, P.A.
    • Dallas, Texas, United States, 75215
      • AIDS Arms, Inc. DBA Prism Health North Texas
    • Houston, Texas, United States, 77098
      • The Crofoot Research Center, INC.
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 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.	Drug: Oral Lenacapavir; Tablets administered without regard to food; Other Names: GS-6207; Sunlenca®; Drug: Subcutaneous Lenacapavir; Administered in the abdomen via subcutaneous injections; Other Names: GS-6207; Sunlenca®; Drug: 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.; Drug: Optimized Background Regimen (OBR); Optimized background regimen as prescribed by the Investigator
Placebo Comparator: 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 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.	Drug: Oral Lenacapavir; Tablets administered without regard to food; Other Names: GS-6207; Sunlenca®; Drug: Subcutaneous Lenacapavir; Administered in the abdomen via subcutaneous injections; Other Names: GS-6207; Sunlenca®; Drug: 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.; Drug: Optimized Background Regimen (OBR); Optimized background regimen as prescribed by the Investigator; Drug: Oral Lenacapavir Placebo; Tablets administered without regard to food
Experimental: 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. 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.	Drug: Oral Lenacapavir; Tablets administered without regard to food; Other Names: GS-6207; Sunlenca®; Drug: Subcutaneous Lenacapavir; Administered in the abdomen via subcutaneous injections; Other Names: GS-6207; Sunlenca®; Drug: Optimized Background Regimen (OBR); Optimized background regimen as prescribed by the Investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The percentage of participants in cohort 1 with plasma HIV-1 RNA < 50 copies/mL at Week 26 was analyzed using the United States Food and Drug Administration (US FDA)-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	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	The percentage of participants in cohort 1 with plasma HIV-1 RNA < 200 copies/mL at Week 26 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	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	The percentage of participants in cohort 1 with plasma HIV-1 RNA < 50 copies/mL at Week 52 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.	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	The percentage of participants in cohort 1 with plasma HIV-1 RNA < 200 copies/mL at Week 52 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.	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	The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA < 50 copies/mL at Week 104 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.	Week 104 (104 weeks after first dose of subcutaneous lenacapavir)
Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm	The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA < 200 copies/mL at Week 104 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.	Week 104 (104 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 156 Based on the US FDA-defined Snapshot Algorithm	The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA < 50 copies/mL at Week 156 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.	Week 156 (156 weeks after first dose of subcutaneous lenacapavir)
Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 156 Based on the US FDA-defined Snapshot Algorithm	The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA < 200 copies/mL at Week 156 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.	Week 156 (156 weeks after first dose of subcutaneous lenacapavir)

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

General Publications

• 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, 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
• Margot 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.
• Castagna 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
• Margot 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
• Ogbuagu 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
• 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.
• Ogbuagu 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.
• Margot 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.
• Antinori 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
• Ogbuagu 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
• Castagna 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
• Kumar 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
• 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.
• Margot 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
• Stellbrink 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
• 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, 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.
• Margot 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.
• Ogbuagu 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.
• 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.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2019
• Primary Completion (Actual): October 5, 2020
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Urogenital Diseases; Genital Diseases; HIV Infections; Infections; Communicable Diseases; lenacapavir
• Other Study ID Numbers: GS-US-200-4625; 2019-003814-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No