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

HIV-1-infection Clinical Trial

— CAPELLA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04150068
• Other study ID #: GS-US-200-4625
• Secondary ID: 2019-003814-16
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: November 21, 2019
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 living with HIV (PLWH) with multi-drug resistance (MDR).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: December 2025
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• HIV-1-infection
• Infections

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Clinique de médecine urbaine du Quartier Latin	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa
Canada	Maple Leaf Research/Maple Leaf Medical Clinic	Toronto	Ontario
Canada	Vancouver ID Research and Care Centre Society	Vancouver	British Columbia
Dominican Republic	Hospital Dr. Salvador Bienvenido Gautier	Santo Domingo
Dominican Republic	Instituto Dominicano de Estudios Virologicos (IDEV)	Santo Domingo
France	Hôpital Sainte-Marguerite	Marseille
France	Hôpital Bichat-Claude Bernard	Paris
France	Hôpital Saint-Antoine	Paris
France	Hôpital Saint-Louis	Paris
Germany	Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie	Essen
Germany	Universitätsklinikum Frankfurt, Medizinische Klinik II	Frankfurt	Hesse
Germany	ICH Study Center GmbH & Co. KG	Hamburg
Italy	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	Milano
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
Japan	National Hospital Organization Nagoya Medical Center	Nagoya
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Center Hospital of the National Center for Global Health and Medicine	Tokyo
Japan	Tokyo Medical University Hospital	Tokyo
South Africa	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
Spain	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	Sevilla
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taoyuan General Hospital, Ministry of Health and Welfare	Taoyuan City
Thailand	Faculty of Medicine Ramathibodi Hospital, Mahidol University	Bangkok
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok
Thailand	Thai Red Cross AIDS Research Center	Bangkok
Thailand	Faculty of Medicine, Khon Kaen University	Khon Kaen
Thailand	Bamrasnaradura Infectious Diseases Institute	Nonthaburi
United States	Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)	Annandale	Virginia
United States	Atlanta ID Group, PC	Atlanta	Georgia
United States	Emory Hospital Midtown Infectious Disease Clinic	Atlanta	Georgia
United States	Central Texas Clinical Research	Austin	Texas
United States	St Hope Foundation	Bellaire	Texas
United States	Be Well Medical Center	Berkley	Michigan
United States	Jacobi Medical Center	Bronx	New York
United States	Atrium Health- Infectious Disease Consultants	Charlotte	North Carolina
United States	Howard Brown Health Center	Chicago	Illinois
United States	Northstar Healthcare	Chicago	Illinois
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	Midland Florida Clinical Research Center, LLC	DeLand	Florida
United States	New York-Presbyterian/Queens	Flushing	New York
United States	Gary J. Richmond, M.D., P.A.	Fort Lauderdale	Florida
United States	Midway Immunology and Research Center	Fort Pierce	Florida
United States	Floridian Clinical Research	Hialeah	Florida
United States	The Crofoot Research Center, INC.	Houston	Texas
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Mills Clinical Research	Los Angeles	California
United States	Ruane Clinical Research Group Inc	Los Angeles	California
United States	North Shore University Hospital/Division of Infectious Diseases	Manhasset	New York
United States	1265 Union Avenue, 8 East	Memphis	Tennessee
United States	AIDS Healthcare Foundation - South Beach	Miami Beach	Florida
United States	Yale University; School of Medicine	New Haven	Connecticut
United States	Orlando Immunology Center	Orlando	Florida
United States	Eisenhower Health Center at Rimrock	Palm Springs	California
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	One Community Health	Sacramento	California
United States	Southampton Healthcare, Inc.	Saint Louis	Missouri
United States	Chatham County Health Department	Savannah	Georgia
United States	St. Joseph's Hospital Comprehensive Research Institute	Tampa	Florida
United States	Washington Health Institute	Washington	District of Columbia
United States	Triple O Research Institute, P.A.	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Canada,  Dominican Republic,  France,  Germany,  Italy,  Japan,  South Africa,  Spain,  Taiwan,  Thailand, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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

External Links

•   Gilead Clinical Trials Website