LAST UPDATED
March 13, 2026
Clinicaltrials.gov ID
EudraCT ID
OVERVIEW
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 (CAPELLA)
PROTOCOL 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).
View moreParticipation requirements
Age
12 years +
Sex
All
Healthy Volunteers
No
Age
12 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HIV-1-infection
Gender
N/A
Date
November 2019 - October 2020
Study Type
Interventional
Study Phase
Phase 2, Phase 3
Product
Oral Lenacapavir, Oral Lenacapavir Placebo, Subcutaneous Lenacapavir, Failing ARV Regimen, Optimized Background Regimen (OBR)
Eligibility information
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/
Locations
Locations (75)
Ruane Clinical Research Group Inc
Los Angeles, California, United States, 90036
Mills Clinical Research
Los Angeles, California, United States, 90069
Eisenhower Health Center at Rimrock
Palm Springs, California, United States, 92264
Yale University; School of Medicine
New Haven, Connecticut, United States, 06510
Washington Health Institute
Washington D.C., District of Columbia, United States, 20017
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States, 32720
Gary J. Richmond, M.D., P.A.
Fort Lauderdale, Florida, United States, 33316
Midway Immunology and Research Center
Ft. Pierce, Florida, United States, 34982
AIDS Healthcare Foundation - South Beach
Miami Beach, Florida, United States, 33139
St. Joseph's Hospital Comprehensive Research Institute
Tampa, Florida, United States, 33614
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States, 33401
Emory Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, United States, 30308
Chatham County Health Department
Savannah, Georgia, United States, 31401
Southampton Healthcare, Inc.
St Louis, Missouri, United States, 63139
New York-Presbyterian/Queens
Flushing, New York, United States, 11355
North Shore University Hospital/Division of Infectious Diseases
Manhasset, New York, United States, 11030
Atrium Health- Infectious Disease Consultants
Charlotte, North Carolina, United States, 28209
Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
AIDS Arms, Inc. DBA Prism Health North Texas
Dallas, Texas, United States, 75215
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, United States, 75246
The Crofoot Research Center, INC.
Houston, Texas, United States, 77098
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, United States, 22003
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, Canada, V6Z 2C9
Maple Leaf Research/Maple Leaf Medical Clinic
Toronto, Ontario, Canada, M5G 1K2
Clinique de médecine urbaine du Quartier Latin
Montreal, Quebec, Canada, H2L 4E9
Instituto Dominicano de Estudios Virologicos (IDEV)
Santo Domingo, Dominican Republic, 10103
Hospital Dr. Salvador Bienvenido Gautier
Santo Domingo, Dominican Republic, 10514
Universitätsklinikum Frankfurt, Medizinische Klinik II
Frankfurt am Main, Hesse, Germany, 60590
Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie
Essen, Germany, 45122
UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1
Brescia, Italy, 25100
Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele
Milan, Italy, 20127
U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
Roma, Italy, 00149
U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy, 00168
National Hospital Organization Nagoya Medical Center
Nagoya, Japan, 460-0001
National Hospital Organization Osaka National Hospital
Osaka, Japan, 540-0006
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Japan, 1628655
Durban International Clinical Research Site, Enhancing Care Foundation
Durban, South Africa, 4302
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan City, Taiwan, 33004
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Thailand, 11000
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