Study Details

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 (functional monotherapy) in people with human immunodeficiency virus (HIV) (PWH) with multi-drug resistance (MDR).

Participation Requirements

Age

12 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

HIV-1-infection

Gender

N/A

Date

November 2019 - October 2020

Study Type

INTERVENTIONAL

Study Phase

PHASE2, PHASE3

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/Exclusion criteria may apply.

Exclusion Criteria

No Exclusion Criteria present

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

One Community Health

Sacramento, California, United States, 95817

Yale University; School of Medicine

New Haven, Connecticut, United States, 06510

Washington Health Institute

Washington, 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

Fort Pierce, Florida, United States, 34982

Floridian Clinical Research

Hialeah, Florida, United States, 33016

AIDS Healthcare Foundation - South Beach

Miami Beach, Florida, United States, 33139

Orlando Immunology Center

Orlando, Florida, United States, 32803

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

Atlanta ID Group, PC

Atlanta, Georgia, United States, 30309

Chatham County Health Department

Savannah, Georgia, United States, 31401

Howard Brown Health Center

Chicago, Illinois, United States, 60613

Northstar Healthcare

Chicago, Illinois, United States, 60657

Be Well Medical Center

Berkley, Michigan, United States, 48072

Southampton Healthcare, Inc.

Saint Louis, Missouri, United States, 63139

Jacobi Medical Center

Bronx, New York, United States, 10461

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

The Miriam Hospital

Providence, Rhode Island, United States, 02906

1265 Union Avenue, 8 East

Memphis, Tennessee, United States, 38163

Central Texas Clinical Research

Austin, Texas, United States, 78705

St Hope Foundation

Bellaire, Texas, United States, 77401

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

The Ottawa Hospital

Ottawa, Canada, K1H 8L6

Instituto Dominicano de Estudios Virologicos (IDEV)

Santo Domingo, Dominican Republic, 10103

Hospital Dr. Salvador Bienvenido Gautier

Santo Domingo, Dominican Republic, 10514

Hôpital Sainte-Marguerite

Marseille, France, 13009

Hôpital Saint-Louis

Paris, France, 75010

Hôpital Saint-Antoine

Paris, France, 75012

Hôpital Bichat-Claude Bernard

Paris, France, 75018

Universitätsklinikum Frankfurt, Medizinische Klinik II

Frankfurt, Hesse, Germany, 60590

Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie

Essen, Germany, 45122

ICH Study Center GmbH & Co. KG

Hamburg, Germany, 20146

University of Naples Federico II

Bergamo, Italy, 24127

UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1

Brescia, Italy, 25100

Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele

Milano, 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

Tokyo Medical University Hospital

Tokyo, Japan, 1600023

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

Helen Joseph Hospital

Johannesburg, South Africa, 2092

Vx Pharma

Pretoria, South Africa, 87

Perinatal HIV Research Unit (PHRU)

Soweto, South Africa, 2013

Hospital Universitari Germans Trías i Pujol

Badalona, Spain, 08916

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Hospital Universitario La Paz

Madrid, Spain, 28046

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 80756

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 81362

Far Eastern Memorial Hospital

New Taipei City, Taiwan, 22060

National Taiwan University Hospital

Taipei, Taiwan, 10048

Taoyuan General Hospital, Ministry of Health and Welfare

Taoyuan City, Taiwan, 33004

Thai Red Cross AIDS Research Center

Bangkok, Thailand, 10330

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, Thailand, 10400

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Thailand, 10700

Faculty of Medicine, Khon Kaen University

Khon Kaen, Thailand, 40002

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Thailand, 11000

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)