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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)

Primary Purpose

HIV-1-infection

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oral Lenacapavir
Oral Lenacapavir Placebo
Subcutaneous Lenacapavir
Failing ARV Regimen
Optimized Background Regimen (OBR)
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1-infection

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ruane Clinical Research Group Inc
  • Mills Clinical Research
  • Eisenhower Health Center at Rimrock
  • One Community Health
  • Yale University; School of Medicine
  • Washington Health Institute
  • Midland Florida Clinical Research Center, LLC
  • Gary J. Richmond, M.D., P.A.
  • Midway Immunology and Research Center
  • Floridian Clinical Research
  • AIDS Healthcare Foundation - South Beach
  • Orlando Immunology Center
  • St. Joseph's Hospital Comprehensive Research Institute
  • Triple O Research Institute, P.A.
  • Emory Hospital Midtown Infectious Disease Clinic
  • Atlanta ID Group, PC
  • Chatham County Health Department
  • Howard Brown Health Center
  • Northstar Healthcare
  • Be Well Medical Center
  • Southampton Healthcare, Inc.
  • Jacobi Medical Center
  • New York-Presbyterian/Queens
  • North Shore University Hospital/Division of Infectious Diseases
  • Atrium Health- Infectious Disease Consultants
  • Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
  • The Miriam Hospital
  • 1265 Union Avenue, 8 East
  • Central Texas Clinical Research
  • St Hope Foundation
  • AIDS Arms, Inc. DBA Prism Health North Texas
  • North Texas Infectious Diseases Consultants, P.A.
  • The Crofoot Research Center, INC.
  • DCOL Center for Clinical Research
  • Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
  • Vancouver ID Research and Care Centre Society
  • Maple Leaf Research/Maple Leaf Medical Clinic
  • Clinique de médecine urbaine du Quartier Latin
  • The Ottawa Hospital
  • Instituto Dominicano de Estudios Virologicos (IDEV)
  • Hospital Dr. Salvador Bienvenido Gautier
  • Hôpital Sainte-Marguerite
  • Hôpital Saint-Louis
  • Hôpital Saint-Antoine
  • Hôpital Bichat-Claude Bernard
  • Universitätsklinikum Frankfurt, Medizinische Klinik II
  • Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie
  • ICH Study Center GmbH & Co. KG
  • University of Naples Federico II
  • UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1
  • Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele
  • U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
  • U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS
  • National Hospital Organization Nagoya Medical Center
  • National Hospital Organization Osaka National Hospital
  • Tokyo Medical University Hospital
  • Center Hospital of the National Center for Global Health and Medicine
  • Durban International Clinical Research Site, Enhancing Care Foundation
  • Helen Joseph Hospital
  • Vx Pharma
  • Perinatal HIV Research Unit (PHRU)
  • Hospital Universitari Germans Trías i Pujol
  • Hospital Clinic de Barcelona
  • Hospital Universitario La Paz
  • Hospital Universitario Virgen del Rocío
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung Veterans General Hospital
  • Far Eastern Memorial Hospital
  • National Taiwan University Hospital
  • Taoyuan General Hospital, Ministry of Health and Welfare
  • Thai Red Cross AIDS Research Center
  • Faculty of Medicine Ramathibodi Hospital, Mahidol University
  • Faculty of Medicine Siriraj Hospital, Mahidol University
  • Faculty of Medicine, Khon Kaen University
  • Bamrasnaradura Infectious Diseases Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Cohort 1A: Lenacapavir

Cohort 1B: Placebo to Lenacapavir

Cohort 2: Lenacapavir

Arm Description

Participants with human-immunodeficiency virus-1 ribonucleic acid (HIV-1 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 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive subcutaneous (SC) lenacapavir 927 mg and will initiate an OBR at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants will receive their subsequent SC lenacapavir injection at Week 26 Visit (relative to Day 1 SC). 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 product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country.

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 lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive oral lenacapavir 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 lenacapavir), participants will receive SC lenacapavir 927 mg while continuing OBR. Participants will receive their next SC injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir 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 study in the country.

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 lenacapavir 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 lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants will receive their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given the 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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
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

Full Information

First Posted
October 28, 2019
Last Updated
August 28, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04150068
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 21, 2019 (Actual)
Primary Completion Date
October 5, 2020 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1-infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1A: Lenacapavir
Arm Type
Experimental
Arm Description
Participants with human-immunodeficiency virus-1 ribonucleic acid (HIV-1 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 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive subcutaneous (SC) lenacapavir 927 mg and will initiate an OBR at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants will receive their subsequent SC lenacapavir injection at Week 26 Visit (relative to Day 1 SC). 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 product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country.
Arm Title
Cohort 1B: Placebo to Lenacapavir
Arm Type
Placebo Comparator
Arm Description
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 lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive oral lenacapavir 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 lenacapavir), participants will receive SC lenacapavir 927 mg while continuing OBR. Participants will receive their next SC injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir 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 study in the country.
Arm Title
Cohort 2: Lenacapavir
Arm Type
Experimental
Arm Description
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 lenacapavir 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 lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants will receive their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given the 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.
Intervention Type
Drug
Intervention Name(s)
Oral Lenacapavir
Other Intervention Name(s)
Sunlenca®, GS-6207
Intervention Description
Tablets administered without regard to food
Intervention Type
Drug
Intervention Name(s)
Oral Lenacapavir Placebo
Intervention Description
Tablets administered without regard to food
Intervention Type
Drug
Intervention Name(s)
Subcutaneous Lenacapavir
Other Intervention Name(s)
Sunlenca®, GS-6207
Intervention Description
Administered in the abdomen via subcutaneous injections
Intervention Type
Drug
Intervention Name(s)
Failing ARV Regimen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Optimized Background Regimen (OBR)
Intervention Description
Optimized background regimen as prescribed by the Investigator
Primary Outcome Measure Information:
Title
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
Time Frame
Baseline up to Day 1 SC Visit (14 days after the first dose of oral lencapavir) or Day 15
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
Title
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
Description
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.
Time Frame
Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
Title
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
Time Frame
Week 52
Title
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
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Ruane Clinical Research Group Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Mills Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Eisenhower Health Center at Rimrock
City
Palm Springs
State/Province
California
ZIP/Postal Code
92264
Country
United States
Facility Name
One Community Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Yale University; School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Washington Health Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
Country
United States
Facility Name
Midland Florida Clinical Research Center, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Gary J. Richmond, M.D., P.A.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Midway Immunology and Research Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Floridian Clinical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
AIDS Healthcare Foundation - South Beach
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
St. Joseph's Hospital Comprehensive Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Triple O Research Institute, P.A.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Emory Hospital Midtown Infectious Disease Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Atlanta ID Group, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Chatham County Health Department
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31401
Country
United States
Facility Name
Howard Brown Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
Northstar Healthcare
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Be Well Medical Center
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Facility Name
Southampton Healthcare, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
New York-Presbyterian/Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
North Shore University Hospital/Division of Infectious Diseases
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Atrium Health- Infectious Disease Consultants
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
1265 Union Avenue, 8 East
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
St Hope Foundation
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
AIDS Arms, Inc. DBA Prism Health North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75215
Country
United States
Facility Name
North Texas Infectious Diseases Consultants, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The Crofoot Research Center, INC.
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
DCOL Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Vancouver ID Research and Care Centre Society
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C9
Country
Canada
Facility Name
Maple Leaf Research/Maple Leaf Medical Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1K2
Country
Canada
Facility Name
Clinique de médecine urbaine du Quartier Latin
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4E9
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Instituto Dominicano de Estudios Virologicos (IDEV)
City
Santo Domingo
ZIP/Postal Code
10103
Country
Dominican Republic
Facility Name
Hospital Dr. Salvador Bienvenido Gautier
City
Santo Domingo
ZIP/Postal Code
10514
Country
Dominican Republic
Facility Name
Hôpital Sainte-Marguerite
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Bichat-Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Universitätsklinikum Frankfurt, Medizinische Klinik II
City
Frankfurt
State/Province
Hesse
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
ICH Study Center GmbH & Co. KG
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
University of Naples Federico II
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1
City
Brescia
ZIP/Postal Code
25100
Country
Italy
Facility Name
Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
1600023
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Tokyo
ZIP/Postal Code
1628655
Country
Japan
Facility Name
Durban International Clinical Research Site, Enhancing Care Foundation
City
Durban
ZIP/Postal Code
4302
Country
South Africa
Facility Name
Helen Joseph Hospital
City
Johannesburg
ZIP/Postal Code
2092
Country
South Africa
Facility Name
Vx Pharma
City
Pretoria
ZIP/Postal Code
87
Country
South Africa
Facility Name
Perinatal HIV Research Unit (PHRU)
City
Soweto
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Hospital Universitari Germans Trías i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
22060
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Taoyuan General Hospital, Ministry of Health and Welfare
City
Taoyuan City
ZIP/Postal Code
33004
Country
Taiwan
Facility Name
Thai Red Cross AIDS Research Center
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Faculty of Medicine Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Faculty of Medicine, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Bamrasnaradura Infectious Diseases Institute
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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.
Results Reference
background
PubMed Identifier
35544387
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.
Results Reference
derived
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-200-4625
Description
Gilead Clinical Trials Website

Learn more about this trial

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

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