Clinical trial NCT04150068: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: HIV-1-infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 72
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline up to Day 1 SC Visit (14 days after the first dose of oral lencapavir) or Day 15
Secondary outcomes:
measure: 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
timeFrame: Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
measure: 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
timeFrame: Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
measure: 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
timeFrame: Week 52
measure: 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
timeFrame: Week 52
measure: Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL From the First Subcutaneous (SC) Dose of Lenacapavir Based on the US FDA-defined Snapshot Algorithm
timeFrame: Week 104
measure: Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL From the First SC Dose of Lenacapavir Based on the US FDA-defined Snapshot Algorithm
timeFrame: Week 104
measure: Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL From the First SC Dose of Lenacapavir Based on the US FDA-defined Snapshot Algorithm
timeFrame: Week 156
measure: Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL From the First SC Dose of Lenacapavir Based on the US FDA-defined Snapshot Algorithm
timeFrame: Week 156
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group Inc
state: California
city: Los Angeles
country: United States
facility: Mills Clinical Research
state: California
city: Palm Springs
country: United States
facility: Eisenhower Health Center at Rimrock
state: California
city: Sacramento
country: United States
facility: One Community Health
state: California
city: New Haven
country: United States
facility: Yale University; School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Washington Health Institute
state: District of Columbia
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Gary J. Richmond, M.D., P.A.
state: Florida
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center
state: Florida
city: Hialeah
country: United States
facility: Floridian Clinical Research
state: Florida
city: Miami Beach
country: United States
facility: AIDS Healthcare Foundation - South Beach
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Hospital Comprehensive Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute, P.A.
state: Florida
city: Atlanta
country: United States
facility: Emory Hospital Midtown Infectious Disease Clinic
state: Georgia
city: Atlanta
country: United States
facility: Atlanta ID Group, PC
state: Georgia
city: Savannah
country: United States
facility: Chatham County Health Department
state: Georgia
city: Chicago
country: United States
facility: Howard Brown Health Center
state: Illinois
city: Chicago
country: United States
facility: Northstar Healthcare
state: Illinois
city: Berkley
country: United States
facility: Be Well Medical Center
state: Michigan
city: Saint Louis
country: United States
facility: Southampton Healthcare, Inc.
state: Missouri
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Flushing
country: United States
facility: New York-Presbyterian/Queens
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital/Division of Infectious Diseases
state: New York
city: Charlotte
country: United States
facility: Atrium Health- Infectious Disease Consultants
state: North Carolina
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Memphis
country: United States
facility: 1265 Union Avenue, 8 East
state: Tennessee
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Bellaire
country: United States
facility: St Hope Foundation
state: Texas
city: Dallas
country: United States
facility: AIDS Arms, Inc. DBA Prism Health North Texas
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants, P.A.
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center, INC.
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Annandale
country: United States
facility: Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
state: Virginia
city: Vancouver
country: Canada
facility: Vancouver ID Research and Care Centre Society
state: British Columbia
city: Toronto
country: Canada
facility: Maple Leaf Research/Maple Leaf Medical Clinic
state: Ontario
city: Montreal
country: Canada
facility: Clinique de médecine urbaine du Quartier Latin
state: Quebec
city: Ottawa
country: Canada
facility: The Ottawa Hospital
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dominicano de Estudios Virologicos (IDEV)
city: Santo Domingo
country: Dominican Republic
facility: Hospital Dr. Salvador Bienvenido Gautier
city: Marseille
country: France
facility: Hôpital Sainte-Marguerite
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Paris
country: France
facility: Hôpital Bichat-Claude Bernard
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt, Medizinische Klinik II
state: Hesse
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie
city: Hamburg
country: Germany
facility: ICH Study Center GmbH & Co. KG
city: Bergamo
country: Italy
facility: University of Naples Federico II
city: Brescia
country: Italy
facility: UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1
city: Milano
country: Italy
facility: Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele
city: Roma
country: Italy
facility: U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
city: Rome
country: Italy
facility: U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Durban
country: South Africa
facility: Durban International Clinical Research Site, Enhancing Care Foundation
city: Johannesburg
country: South Africa
facility: Helen Joseph Hospital
city: Pretoria
country: South Africa
facility: Vx Pharma
city: Soweto
country: South Africa
facility: Perinatal HIV Research Unit (PHRU)
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trías i Pujol
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: Taoyuan General Hospital, Ministry of Health and Welfare
city: Bangkok
country: Thailand
facility: Thai Red Cross AIDS Research Center
city: Bangkok
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
city: Khon Kaen
country: Thailand
facility: Faculty of Medicine, Khon Kaen University
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Infectious Diseases Institute
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.