CAPELLA: 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

Sponsor
Gilead Sciences (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04150068
Collaborator
(none)
72
75
3
46.3
1
0

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Oral Lenacapavir
  • Drug: Oral Lenacapavir Placebo
  • Drug: Subcutaneous Lenacapavir
  • Drug: Failing ARV Regimen
  • Drug: Optimized Background Regimen (OBR)
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 21, 2019
Actual Primary Completion Date :
Oct 5, 2020
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1A: Lenacapavir

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.

Drug: Oral Lenacapavir
Tablets administered without regard to food
Other Names:
  • GS-6207
  • Drug: Subcutaneous Lenacapavir
    Administered in the abdomen via subcutaneous injections
    Other Names:
  • GS-6207
  • Drug: 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.

    Drug: Optimized Background Regimen (OBR)
    Optimized background regimen as prescribed by the Investigator

    Placebo Comparator: Cohort 1B: Placebo to Lenacapavir

    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.

    Drug: Oral Lenacapavir
    Tablets administered without regard to food
    Other Names:
  • GS-6207
  • Drug: Oral Lenacapavir Placebo
    Tablets administered without regard to food

    Drug: Subcutaneous Lenacapavir
    Administered in the abdomen via subcutaneous injections
    Other Names:
  • GS-6207
  • Drug: 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.

    Drug: Optimized Background Regimen (OBR)
    Optimized background regimen as prescribed by the Investigator

    Experimental: Cohort 2: Lenacapavir

    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.

    Drug: Oral Lenacapavir
    Tablets administered without regard to food
    Other Names:
  • GS-6207
  • Drug: Subcutaneous Lenacapavir
    Administered in the abdomen via subcutaneous injections
    Other Names:
  • GS-6207
  • Drug: Optimized Background Regimen (OBR)
    Optimized background regimen as prescribed by the Investigator

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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 [Week 26 (26 weeks after first dose of subcutaneous lenacapavir)]

      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.

    2. 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 [Week 26 (26 weeks after first dose of subcutaneous lenacapavir)]

      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.

    3. 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]

    4. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ruane Clinical Research Group Inc Los Angeles California United States 90036
    2 Mills Clinical Research Los Angeles California United States 90069
    3 Eisenhower Health Center at Rimrock Palm Springs California United States 92264
    4 One Community Health Sacramento California United States 95817
    5 Yale University; School of Medicine New Haven Connecticut United States 06510
    6 Washington Health Institute Washington District of Columbia United States 20017
    7 Midland Florida Clinical Research Center, LLC DeLand Florida United States 32720
    8 Gary J. Richmond, M.D., P.A. Fort Lauderdale Florida United States 33316
    9 Midway Immunology and Research Center Fort Pierce Florida United States 34982
    10 Floridian Clinical Research Hialeah Florida United States 33016
    11 AIDS Healthcare Foundation - South Beach Miami Beach Florida United States 33139
    12 Orlando Immunology Center Orlando Florida United States 32803
    13 St. Joseph's Hospital Comprehensive Research Institute Tampa Florida United States 33614
    14 Triple O Research Institute, P.A. West Palm Beach Florida United States 33401
    15 Emory Hospital Midtown Infectious Disease Clinic Atlanta Georgia United States 30308
    16 Atlanta ID Group, PC Atlanta Georgia United States 30309
    17 Chatham County Health Department Savannah Georgia United States 31401
    18 Howard Brown Health Center Chicago Illinois United States 60613
    19 Northstar Healthcare Chicago Illinois United States 60657
    20 Be Well Medical Center Berkley Michigan United States 48072
    21 Southampton Healthcare, Inc. Saint Louis Missouri United States 63139
    22 Jacobi Medical Center Bronx New York United States 10461
    23 New York-Presbyterian/Queens Flushing New York United States 11355
    24 North Shore University Hospital/Division of Infectious Diseases Manhasset New York United States 11030
    25 Atrium Health- Infectious Disease Consultants Charlotte North Carolina United States 28209
    26 Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    27 The Miriam Hospital Providence Rhode Island United States 02906
    28 1265 Union Avenue, 8 East Memphis Tennessee United States 38163
    29 Central Texas Clinical Research Austin Texas United States 78705
    30 St Hope Foundation Bellaire Texas United States 77401
    31 AIDS Arms, Inc. DBA Prism Health North Texas Dallas Texas United States 75215
    32 North Texas Infectious Diseases Consultants, P.A. Dallas Texas United States 75246
    33 The Crofoot Research Center, INC. Houston Texas United States 77098
    34 DCOL Center for Clinical Research Longview Texas United States 75605
    35 Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID) Annandale Virginia United States 22003
    36 Vancouver ID Research and Care Centre Society Vancouver British Columbia Canada V6Z 2C9
    37 Maple Leaf Research/Maple Leaf Medical Clinic Toronto Ontario Canada M5G 1K2
    38 Clinique de médecine urbaine du Quartier Latin Montreal Quebec Canada H2L 4E9
    39 The Ottawa Hospital Ottawa Canada K1H 8L6
    40 Instituto Dominicano de Estudios Virologicos (IDEV) Santo Domingo Dominican Republic 10103
    41 Hospital Dr. Salvador Bienvenido Gautier Santo Domingo Dominican Republic 10514
    42 Hôpital Sainte-Marguerite Marseille France 13009
    43 Hôpital Saint-Louis Paris France 75010
    44 Hôpital Saint-Antoine Paris France 75012
    45 Hôpital Bichat-Claude Bernard Paris France 75018
    46 Universitätsklinikum Frankfurt, Medizinische Klinik II Frankfurt Hesse Germany 60590
    47 Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie Essen Germany 45122
    48 ICH Study Center GmbH & Co. KG Hamburg Germany 20146
    49 University of Naples Federico II Bergamo Italy 24127
    50 UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1 Brescia Italy 25100
    51 Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele Milano Italy 20127
    52 U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS Roma Italy 00149
    53 U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy 00168
    54 National Hospital Organization Nagoya Medical Center Nagoya Japan 460-0001
    55 National Hospital Organization Osaka National Hospital Osaka Japan 540-0006
    56 Tokyo Medical University Hospital Tokyo Japan 1600023
    57 Center Hospital of the National Center for Global Health and Medicine Tokyo Japan 1628655
    58 Durban International Clinical Research Site, Enhancing Care Foundation Durban South Africa 4302
    59 Helen Joseph Hospital Johannesburg South Africa 2092
    60 Vx Pharma Pretoria South Africa 87
    61 Perinatal HIV Research Unit (PHRU) Soweto South Africa 2013
    62 Hospital Universitari Germans Trías i Pujol Badalona Spain 08916
    63 Hospital Clinic de Barcelona Barcelona Spain 08036
    64 Hospital Universitario La Paz Madrid Spain 28046
    65 Hospital Universitario Virgen del Rocío Sevilla Spain 41013
    66 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 80756
    67 Kaohsiung Veterans General Hospital Kaohsiung Taiwan 81362
    68 Far Eastern Memorial Hospital New Taipei City Taiwan 22060
    69 National Taiwan University Hospital Taipei Taiwan 10048
    70 Taoyuan General Hospital, Ministry of Health and Welfare Taoyuan City Taiwan 33004
    71 Thai Red Cross AIDS Research Center Bangkok Thailand 10330
    72 Faculty of Medicine Ramathibodi Hospital, Mahidol University Bangkok Thailand 10400
    73 Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok Thailand 10700
    74 Faculty of Medicine, Khon Kaen University Khon Kaen Thailand 40002
    75 Bamrasnaradura Infectious Diseases Institute Nonthaburi Thailand 11000

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT04150068
    Other Study ID Numbers:
    • GS-US-200-4625
    • 2019-003814-16
    First Posted:
    Nov 4, 2019
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in the United States, Thailand, Italy, Dominican Republic, Spain, France, Canada, Taiwan, South Africa, Japan, and Germany. The first participant was screened on 21 November 2019. Data submitted represent interim analysis performed on data collected by the Primary Completion Date 05 October 2020, and additional data collected after all participants in Cohort 1 completed Week 26 visit.
    Pre-assignment Detail 144 participants were screened.
    Arm/Group Title Cohort 1A: Lenacapavir Cohort 1B: Placebo to Lenacapavir Cohort 2: Lenacapavir
    Arm/Group 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 the Cohort Selection visit compared with screening visit received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous anti-retroviral [ARV] regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received subcutaneous (SC) lenacapavir 927 mg and initiated an optimized background regimen (OBR; as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received 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 an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected 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 received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received 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 an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. Participants were enrolled in Cohort 2 if Cohort 1 was fully enrolled or if they did not meet the criteria for randomization in Cohort 1 (ie, they had ≥ 0.5 log10 HIV-1 RNA decline compared to the Screening visit and/or HIV-1 RNA < 400 copies/mL at the Cohort Selection visit). Participants received 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 received SC lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants received 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 became accessible to participants through an access program or until Gilead elected to discontinue the study in the country.
    Period Title: Functional Mono/Oral Lead-in (14 Days)
    STARTED 24 12 36
    COMPLETED 24 12 36
    NOT COMPLETED 0 0 0
    Period Title: Functional Mono/Oral Lead-in (14 Days)
    STARTED 24 12 36
    COMPLETED 0 0 0
    NOT COMPLETED 24 12 36

    Baseline Characteristics

    Arm/Group Title Cohort 1A: Lenacapavir Cohort 1B: Placebo to Lenacapavir Cohort 2: Lenacapavir Total
    Arm/Group 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 received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received SC lenacapavir 927 mg and initiated an OBR (as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received 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 an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected 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 received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received 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 an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. Participants were enrolled in Cohort 2 if Cohort 1 was fully enrolled or if they did not meet the criteria for randomization in Cohort 1 (ie, they had ≥ 0.5 log10 HIV-1 RNA decline compared to the Screening visit and/or HIV-1 RNA < 400 copies/mL at the Cohort Selection visit). Participants received 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 received SC lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants received 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 became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. Total of all reporting groups
    Overall Participants 24 12 36 72
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54
    (11.3)
    49
    (10.9)
    48
    (13.7)
    50
    (12.6)
    Sex: Female, Male (Count of Participants)
    Female
    7
    29.2%
    3
    25%
    8
    22.2%
    18
    25%
    Male
    17
    70.8%
    9
    75%
    28
    77.8%
    54
    75%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    2
    8.3%
    1
    8.3%
    12
    33.3%
    15
    20.8%
    Black
    10
    41.7%
    6
    50%
    11
    30.6%
    27
    37.5%
    White
    12
    50%
    4
    33.3%
    13
    36.1%
    29
    40.3%
    Not Permitted
    0
    0%
    1
    8.3%
    0
    0%
    1
    1.4%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    6
    25%
    4
    33.3%
    5
    13.9%
    15
    20.8%
    Not Hispanic or Latino
    18
    75%
    7
    58.3%
    31
    86.1%
    56
    77.8%
    Not Permitted
    0
    0%
    1
    8.3%
    0
    0%
    1
    1.4%
    Region of Enrollment (Count of Participants)
    Canada
    0
    0%
    0
    0%
    2
    5.6%
    2
    2.8%
    Dominican Republic
    0
    0%
    1
    8.3%
    0
    0%
    1
    1.4%
    France
    0
    0%
    1
    8.3%
    2
    5.6%
    3
    4.2%
    Italy
    1
    4.2%
    0
    0%
    6
    16.7%
    7
    9.7%
    South Africa
    0
    0%
    0
    0%
    1
    2.8%
    1
    1.4%
    Spain
    1
    4.2%
    0
    0%
    0
    0%
    1
    1.4%
    Taiwan
    0
    0%
    0
    0%
    1
    2.8%
    1
    1.4%
    Thailand
    2
    8.3%
    1
    8.3%
    8
    22.2%
    11
    15.3%
    United States
    20
    83.3%
    9
    75%
    13
    36.1%
    42
    58.3%
    Japan
    0
    0%
    0
    0%
    2
    5.6%
    2
    2.8%
    Germany
    0
    0%
    0
    0%
    1
    2.8%
    1
    1.4%
    HIV-1 RNA (log10 copies/mL) (log10 copies/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 copies/mL]
    3.97
    (0.922)
    4.87
    (0.393)
    4.06
    (1.164)
    4.17
    (1.034)
    HIV-1 RNA Categories (Count of Participants)
    ≤ 100000 copies/mL
    23
    95.8%
    6
    50%
    29
    80.6%
    58
    80.6%
    > 100000 copies/mL
    1
    4.2%
    6
    50%
    7
    19.4%
    14
    19.4%

    Outcome Measures

    1. Primary Outcome
    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
    Description
    Time Frame Baseline up to Day 1 SC Visit (14 days after the first dose of oral lencapavir) or Day 15

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set for the Functional Monotherapy Period analysis included participants who were randomized in the Functional Monotherapy Period and received at least 1 dose of blinded study drug.
    Arm/Group Title Cohort 1A: Lenacapavir Cohort 1B: Placebo to Lenacapavir
    Arm/Group 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 received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received SC lenacapavir 927 mg and initiated an OBR (as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received 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 an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected 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 received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received 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 an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country.
    Measure Participants 24 12
    Number [percentage of participants]
    87.5
    364.6%
    16.7
    139.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cohort 1A: Lenacapavir, Cohort 1B: Placebo to Lenacapavir
    Comments
    Type of Statistical Test Superiority
    Comments The difference in percentage between 2 treatment groups was compared using an unconditional exact method using 2 invert 1-sided tests with an alpha level at 0.05 to evaluate superiority.
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments The P value and 95% confidence interval (CI) for the point estimate of treatment difference in proportions was estimated and constructed using the Chan and Zhang method.
    Method Chan & Zhang method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 70.8
    Confidence Interval (2-Sided) 95%
    34.9 to 90.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set for the All Lenacapavir Analysis included participants who were enrolled into the study and received at least 1 dose of SC lenacapavir.
    Arm/Group Title Cohort 1A: Lenacapavir Cohort 1B: Placebo to Lenacapavir
    Arm/Group 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 received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received SC lenacapavir 927 mg and initiated an OBR (as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received 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 an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected 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 received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received 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 an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country.
    Measure Participants 24 12
    Number (95% Confidence Interval) [percentage of participants]
    87.5
    364.6%
    66.7
    555.8%
    3. Secondary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis set for the All Lenacapavir Analysis were analyzed.
    Arm/Group Title Cohort 1A: Lenacapavir Cohort 1B: Placebo to Lenacapavir
    Arm/Group 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 received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received SC lenacapavir 927 mg and initiated an OBR (as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received 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 an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected 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 received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received 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 an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country.
    Measure Participants 24 12
    Number (95% Confidence Interval) [percentage of participants]
    95.8
    399.2%
    75.0
    625%
    4. Secondary Outcome
    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
    Description
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    5. Secondary Outcome
    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
    Description
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame All-Cause Mortality: Enrollment up to Week 26 (26 weeks after first dose of subcutaneous lenacapavir); Adverse Events: First dose date up to Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
    Adverse Event Reporting Description All-Cause Mortality: All Enrolled Analysis Set included participants who were randomized into Cohort 1 or enrolled into Cohort 2. Adverse events: Safety Analysis Set included participants who were enrolled and received at least 1 dose of study drug.
    Arm/Group Title Cohort 1A: Lenacapavir Cohort 1B: Placebo to Lenacapavir Cohort 2: Lenacapavir
    Arm/Group 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 received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received SC lenacapavir 927 mg and initiated an OBR (as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received 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 an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected 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 received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received 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 an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country. Participants were enrolled in Cohort 2 if Cohort 1 was fully enrolled or if they did not meet the criteria for randomization in Cohort 1 (ie, they had ≥ 0.5 log10 HIV-1 RNA decline compared to the Screening visit and/or HIV-1 RNA < 400 copies/mL at the Cohort Selection visit). Participants received 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 received SC lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants received 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 became accessible to participants through an access program or until Gilead elected to discontinue the study in the country.
    All Cause Mortality
    Cohort 1A: Lenacapavir Cohort 1B: Placebo to Lenacapavir Cohort 2: Lenacapavir
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/24 (0%) 0/12 (0%) 1/36 (2.8%)
    Serious Adverse Events
    Cohort 1A: Lenacapavir Cohort 1B: Placebo to Lenacapavir Cohort 2: Lenacapavir
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/24 (4.2%) 1/12 (8.3%) 2/36 (5.6%)
    Gastrointestinal disorders
    Abdominal pain 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Pancreatic mass 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Proctalgia 1/24 (4.2%) 0/12 (0%) 0/36 (0%)
    Infections and infestations
    Clostridium difficile infection 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Injury, poisoning and procedural complications
    Femoral neck fracture 0/24 (0%) 0/12 (0%) 1/36 (2.8%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm malignant 0/24 (0%) 0/12 (0%) 1/36 (2.8%)
    Nervous system disorders
    Dizziness 0/24 (0%) 0/12 (0%) 1/36 (2.8%)
    Other (Not Including Serious) Adverse Events
    Cohort 1A: Lenacapavir Cohort 1B: Placebo to Lenacapavir Cohort 2: Lenacapavir
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 20/24 (83.3%) 11/12 (91.7%) 30/36 (83.3%)
    Blood and lymphatic system disorders
    Lymphadenopathy 0/24 (0%) 2/12 (16.7%) 0/36 (0%)
    Thrombocytopenia 0/24 (0%) 1/12 (8.3%) 1/36 (2.8%)
    Ear and labyrinth disorders
    Cerumen impaction 1/24 (4.2%) 1/12 (8.3%) 0/36 (0%)
    Ear swelling 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Endocrine disorders
    Hypogonadism 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Eye disorders
    Eye pruritus 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Gastrointestinal disorders
    Abdominal distension 3/24 (12.5%) 0/12 (0%) 1/36 (2.8%)
    Abdominal pain upper 0/24 (0%) 2/12 (16.7%) 0/36 (0%)
    Anal fissure 0/24 (0%) 1/12 (8.3%) 1/36 (2.8%)
    Constipation 2/24 (8.3%) 2/12 (16.7%) 0/36 (0%)
    Diarrhoea 3/24 (12.5%) 2/12 (16.7%) 1/36 (2.8%)
    Nausea 4/24 (16.7%) 1/12 (8.3%) 1/36 (2.8%)
    Toothache 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Vomiting 0/24 (0%) 1/12 (8.3%) 3/36 (8.3%)
    General disorders
    Asthenia 0/24 (0%) 1/12 (8.3%) 2/36 (5.6%)
    Fatigue 3/24 (12.5%) 0/12 (0%) 0/36 (0%)
    Injection site erythema 7/24 (29.2%) 2/12 (16.7%) 10/36 (27.8%)
    Injection site induration 2/24 (8.3%) 0/12 (0%) 7/36 (19.4%)
    Injection site nodule 8/24 (33.3%) 4/12 (33.3%) 2/36 (5.6%)
    Injection site oedema 1/24 (4.2%) 0/12 (0%) 2/36 (5.6%)
    Injection site pain 7/24 (29.2%) 2/12 (16.7%) 9/36 (25%)
    Injection site pruritus 2/24 (8.3%) 0/12 (0%) 1/36 (2.8%)
    Injection site swelling 9/24 (37.5%) 3/12 (25%) 9/36 (25%)
    Pain 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Pyrexia 1/24 (4.2%) 2/12 (16.7%) 2/36 (5.6%)
    Infections and infestations
    Abscess limb 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Covid-19 1/24 (4.2%) 0/12 (0%) 2/36 (5.6%)
    Ear infection 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Gastroenteritis 2/24 (8.3%) 1/12 (8.3%) 0/36 (0%)
    Infected skin ulcer 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Nasopharyngitis 0/24 (0%) 1/12 (8.3%) 1/36 (2.8%)
    Oesophageal candidiasis 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Oral candidiasis 1/24 (4.2%) 2/12 (16.7%) 1/36 (2.8%)
    Oral herpes 0/24 (0%) 2/12 (16.7%) 0/36 (0%)
    Osteomyelitis 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Tinea versicolour 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Urinary tract infection 2/24 (8.3%) 0/12 (0%) 3/36 (8.3%)
    Investigations
    Weight decreased 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 2/24 (8.3%) 0/12 (0%) 0/36 (0%)
    Hyperglycaemia 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Hyperlipidaemia 2/24 (8.3%) 0/12 (0%) 0/36 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 4/24 (16.7%) 0/12 (0%) 0/36 (0%)
    Back pain 0/24 (0%) 1/12 (8.3%) 3/36 (8.3%)
    Muscular weakness 2/24 (8.3%) 0/12 (0%) 0/36 (0%)
    Myalgia 1/24 (4.2%) 0/12 (0%) 2/36 (5.6%)
    Neck pain 1/24 (4.2%) 2/12 (16.7%) 0/36 (0%)
    Nervous system disorders
    Dizziness 1/24 (4.2%) 0/12 (0%) 2/36 (5.6%)
    Headache 2/24 (8.3%) 0/12 (0%) 3/36 (8.3%)
    Neuropathy peripheral 2/24 (8.3%) 0/12 (0%) 0/36 (0%)
    Somnolence 0/24 (0%) 0/12 (0%) 2/36 (5.6%)
    Psychiatric disorders
    Insomnia 0/24 (0%) 0/12 (0%) 2/36 (5.6%)
    Sleep disorder 0/24 (0%) 1/12 (8.3%) 1/36 (2.8%)
    Renal and urinary disorders
    Glycosuria 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Haematuria 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Pollakiuria 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Proteinuria 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Reproductive system and breast disorders
    Vaginal discharge 0/24 (0%) 0/12 (0%) 3/36 (8.3%)
    Respiratory, thoracic and mediastinal disorders
    Cough 2/24 (8.3%) 2/12 (16.7%) 1/36 (2.8%)
    Dyspnoea 1/24 (4.2%) 1/12 (8.3%) 1/36 (2.8%)
    Epistaxis 1/24 (4.2%) 1/12 (8.3%) 0/36 (0%)
    Haemoptysis 2/24 (8.3%) 0/12 (0%) 0/36 (0%)
    Nasal congestion 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Wheezing 1/24 (4.2%) 1/12 (8.3%) 0/36 (0%)
    Skin and subcutaneous tissue disorders
    Bullous haemorrhagic dermatosis 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Dry skin 0/24 (0%) 1/12 (8.3%) 1/36 (2.8%)
    Prurigo 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Pruritus 1/24 (4.2%) 1/12 (8.3%) 1/36 (2.8%)
    Rash 2/24 (8.3%) 0/12 (0%) 2/36 (5.6%)
    Rash macular 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Rash papular 0/24 (0%) 2/12 (16.7%) 0/36 (0%)
    Rash pruritic 0/24 (0%) 0/12 (0%) 2/36 (5.6%)
    Skin ulcer 0/24 (0%) 1/12 (8.3%) 0/36 (0%)
    Surgical and medical procedures
    Tooth extraction 0/24 (0%) 1/12 (8.3%) 0/36 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Gilead Clinical Study Information Center
    Organization Gilead Sciences
    Phone 1-833-445-3230 (GILEAD-0)
    Email GileadClinicalTrials@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT04150068
    Other Study ID Numbers:
    • GS-US-200-4625
    • 2019-003814-16
    First Posted:
    Nov 4, 2019
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022