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A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

Primary Purpose

HIV Infections

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Teropavimab
Zinlirvimab
Lenacapavir Tablet
Lenacapavir Injection
Antiretroviral Therapy
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit 2. A change in ART regimen ≥ 28 days prior to screening visit 2 for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed. No clinically significant documented historical resistance to the current ART regimen with the exception of isolated nucleoside reverse transcriptase inhibitor mutations including M184V or ≤ 2 thymidine analog mutations (TAMs: M41L, D67N, K70R, L210W, T215Y, and/or K219Q). Plasma HIV-1 RNA < 50 copies/mL at screening visit 2. Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 12 months preceding screening visit 2 (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Virologic elevations of ≥ 50 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable. Proviral pheynotypic sensitivity to both teropavimab and zinlirvimab at screening or from protocol GS-US-536-5816 within 24 months prior to screening. Screening CD4+ T-cell count ≥ 200 cells/μL at screening visit 2. Key Exclusion Criteria: Comorbid condition requiring ongoing immunosuppression. Evidence of hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable) Evidence of current hepatitis B virus (HBV) infection regardless of HBV surface antigen status, at the screening visit 2. History of opportunistic infection or illness indicative of Stage 3 HIV disease. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Ruane Clinical Research Group, Inc.Recruiting
  • Mills Clinical ResearchRecruiting
  • UC San Diego (UCSD) AntiViral Research Center (AVRC)Recruiting
  • Optimus Medical GroupRecruiting
  • University of Colorado Clinical and Translational Research CenterRecruiting
  • Yale University; School of Medicine; AIDS ProgramRecruiting
  • Georgetown University Medical CenterRecruiting
  • Midland Florida Clinical Research Center, LLCRecruiting
  • Can Community Health CareRecruiting
  • Midway Immunology and Research CenterRecruiting
  • Orlando Immunology CenterRecruiting
  • Triple O Research Institute, P.A.Recruiting
  • Emory University Hospital Midtown Infectious Disease ClinicRecruiting
  • Infectious Disease Specialists of AtlantaRecruiting
  • Be Well Medical CenterRecruiting
  • Southhampton Healthcare, IncRecruiting
  • ID Care, P.A.Recruiting
  • AXCES Research Group, LLCRecruiting
  • Montefiore Medical CenterRecruiting
  • NC TraCS Institute - CTRC; University of North Carolina at Chapel HillRecruiting
  • Duke University Health CenterRecruiting
  • Regional Center for Infectious Disease ResearchRecruiting
  • The Brody School of Medicine at East Carolina UniversityRecruiting
  • Rosedale Health and WellnessRecruiting
  • Prisma Health - Clinical Research UnitRecruiting
  • St Jude Children's Research HospitalRecruiting
  • Central Texas Clinical ResearchRecruiting
  • AIDS Arms, Inc. DBA Prism Health North TexasRecruiting
  • North Texas Infectious Diseases Consultant's, P.A.Recruiting
  • AXCES Research Group, LLCRecruiting
  • The Crofoot Research Center, INCRecruiting
  • Clinical Alliance for Research & Education, Infectious Diseases LLC (CARE-ID)Recruiting
  • East Sydney DoctorsRecruiting
  • Holdsworth House Medical PracticeRecruiting
  • Monash HealthRecruiting
  • Alfred HospitalRecruiting
  • CMU Quartier Latin Inc
  • The Ottawa Hospital - General CampusRecruiting
  • Maple Leaf Research/Maple Leaf Medical ClinicRecruiting
  • University Health Network - Toronto General HospitalRecruiting
  • Clinical Research Puerto RicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Randomized Phase: Lenacapavir (LEN) + Teropavimab Dose A + Zinlirvimab Dose B

Randomized Phase: Antiretroviral Therapy (ART)

Extension Phase: LEN + Teropavimab Dose A + Zinlirvimab Dose B

Extension Phase: ART

Arm Description

Participants will receive oral LEN 600mg, subcutaneous (SC) LEN 927 mg, teropavimab Dose A, and zinlirvimab Dose B on Day 1. Participants will self-administer oral LEN 600 mg on Day 2. The last treatment regimen will include SC LEN + teropavimab Dose A + zinlirvimab Dose B.

Participants will continue their baseline oral ART through Week 52.

At Week 52, participants who receive the study drug of LEN, teropavimab, zinlirvimab, and complete study through Week 52 with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL will be given the option to participate in the study extension phase, where they will continue to receive their randomized study drugs treatment regimen until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years.

Participants who complete study through Week 52 with HIV-1 RNA < 50 copies/mL and in the absence of confirmed virologic rebound (VR) throughout the randomized phase of the study will be given the option to participate in the extension phase and receive the study drugs of LEN, teropavimab, and zinlirvimab at the dose specified for randomized phase until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years. Treatment with study drug will begin at Week 52 and at that time the baseline oral ART will be discontinued.

Outcomes

Primary Outcome Measures

Proportion of Participants with Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-defined Snapshot Algorithm

Secondary Outcome Measures

Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm
Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
Change from Baseline in Clusters of Differentiation 4 (CD4)+ T-cell Counts at Week 26
Change from Baseline in Clusters of Differentiation 4 (CD4)+ T-cell Counts at Week 52
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Trough Concentration at Week 26 for GS-5423, GS-2872, and LEN
Trough Concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
Trough Concentration at Week 52 for GS-5423, GS-2872, and LEN
Trough Concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
Pharmacokinetic (PK) Parameter: AUC0-t for GS-5423, GS-2872, and LEN
AUC0-t is defined as the partial area under the concentration versus time curve from time "0" to time "t".
PK Parameter: AUClast for GS-5423, GS-2872, and LEN
AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
PK Parameter: t1/2 for GS-5423, GS-2872, and LEN
t1/2 is defined as the terminal elimination half-life.
PK Parameter: Cmax for GS-5423, GS-2872, and LEN
Cmax is defined as the maximum observed concentration of drug.
PK Parameter: Tmax for GS-5423, GS-2872, and LEN
Tmax is defined as the time (observed time point) of Cmax.
Proportion of Participants with Treatment-emergent Anti-GS-5423 Antibodies
Proportion of Participants with Treatment-emergent Anti-GS-2872 Antibodies

Full Information

First Posted
February 6, 2023
Last Updated
October 6, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05729568
Brief Title
A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
Official Title
A Phase 2 Randomized, Open-label Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With the Capsid Inhibitor Lenacapavir as Long-Acting Treatment Dosed Every 6 Months in Virologically Suppressed Adults With HIV-1 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
December 2029 (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 goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection. The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, teropavimab, and zinlirvimab, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Randomized Phase: Lenacapavir (LEN) + Teropavimab Dose A + Zinlirvimab Dose B
Arm Type
Experimental
Arm Description
Participants will receive oral LEN 600mg, subcutaneous (SC) LEN 927 mg, teropavimab Dose A, and zinlirvimab Dose B on Day 1. Participants will self-administer oral LEN 600 mg on Day 2. The last treatment regimen will include SC LEN + teropavimab Dose A + zinlirvimab Dose B.
Arm Title
Randomized Phase: Antiretroviral Therapy (ART)
Arm Type
Experimental
Arm Description
Participants will continue their baseline oral ART through Week 52.
Arm Title
Extension Phase: LEN + Teropavimab Dose A + Zinlirvimab Dose B
Arm Type
Experimental
Arm Description
At Week 52, participants who receive the study drug of LEN, teropavimab, zinlirvimab, and complete study through Week 52 with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL will be given the option to participate in the study extension phase, where they will continue to receive their randomized study drugs treatment regimen until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years.
Arm Title
Extension Phase: ART
Arm Type
Experimental
Arm Description
Participants who complete study through Week 52 with HIV-1 RNA < 50 copies/mL and in the absence of confirmed virologic rebound (VR) throughout the randomized phase of the study will be given the option to participate in the extension phase and receive the study drugs of LEN, teropavimab, and zinlirvimab at the dose specified for randomized phase until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years. Treatment with study drug will begin at Week 52 and at that time the baseline oral ART will be discontinued.
Intervention Type
Drug
Intervention Name(s)
Teropavimab
Other Intervention Name(s)
GS-5423
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Zinlirvimab
Other Intervention Name(s)
GS-2872
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Lenacapavir Tablet
Other Intervention Name(s)
GS-6207
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Lenacapavir Injection
Other Intervention Name(s)
GS-6207
Intervention Description
Administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Antiretroviral Therapy
Intervention Description
Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide.
Primary Outcome Measure Information:
Title
Proportion of Participants with Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-defined Snapshot Algorithm
Time Frame
Week 26
Secondary Outcome Measure Information:
Title
Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
Time Frame
Week 52
Title
Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm
Time Frame
Week 26
Title
Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
Time Frame
Week 52
Title
Change from Baseline in Clusters of Differentiation 4 (CD4)+ T-cell Counts at Week 26
Time Frame
Baseline, Week 26
Title
Change from Baseline in Clusters of Differentiation 4 (CD4)+ T-cell Counts at Week 52
Time Frame
Baseline, Week 52
Title
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame
First dose date up to end of study (Up to approximately 6 years)
Title
Trough Concentration at Week 26 for GS-5423, GS-2872, and LEN
Description
Trough Concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
Time Frame
Week 26
Title
Trough Concentration at Week 52 for GS-5423, GS-2872, and LEN
Description
Trough Concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
Time Frame
Week 52
Title
Pharmacokinetic (PK) Parameter: AUC0-t for GS-5423, GS-2872, and LEN
Description
AUC0-t is defined as the partial area under the concentration versus time curve from time "0" to time "t".
Time Frame
First dose date up to end of study (Up to approximately 6 years)
Title
PK Parameter: AUClast for GS-5423, GS-2872, and LEN
Description
AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
Time Frame
First dose date up to end of study (Up to approximately 6 years)
Title
PK Parameter: t1/2 for GS-5423, GS-2872, and LEN
Description
t1/2 is defined as the terminal elimination half-life.
Time Frame
First dose date up to end of study (Up to approximately 6 years)
Title
PK Parameter: Cmax for GS-5423, GS-2872, and LEN
Description
Cmax is defined as the maximum observed concentration of drug.
Time Frame
First dose date up to end of study (Up to approximately 6 years)
Title
PK Parameter: Tmax for GS-5423, GS-2872, and LEN
Description
Tmax is defined as the time (observed time point) of Cmax.
Time Frame
First dose date up to end of study (Up to approximately 6 years)
Title
Proportion of Participants with Treatment-emergent Anti-GS-5423 Antibodies
Time Frame
Up to end of study (Up to approximately 6 years)
Title
Proportion of Participants with Treatment-emergent Anti-GS-2872 Antibodies
Time Frame
Up to end of study (Up to approximately 6 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit 2. A change in ART regimen ≥ 28 days prior to screening visit 2 for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed. No clinically significant documented historical resistance to the current ART regimen with the exception of isolated nucleoside reverse transcriptase inhibitor mutations including M184V or ≤ 2 thymidine analog mutations (TAMs: M41L, D67N, K70R, L210W, T215Y, and/or K219Q). Plasma HIV-1 RNA < 50 copies/mL at screening visit 2. Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 12 months preceding screening visit 2 (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Virologic elevations of ≥ 50 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable. Proviral pheynotypic sensitivity to both teropavimab and zinlirvimab at screening or from protocol GS-US-536-5816 within 24 months prior to screening. Screening CD4+ T-cell count ≥ 200 cells/μL at screening visit 2. Key Exclusion Criteria: Comorbid condition requiring ongoing immunosuppression. Evidence of hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable) Evidence of current hepatitis B virus (HBV) infection regardless of HBV surface antigen status, at the screening visit 2. History of opportunistic infection or illness indicative of Stage 3 HIV disease. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilead Clinical Study Information Center
Phone
1-833-445-3230 (GILEAD-0)
Email
GileadClinicalTrials@gilead.com
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
Individual Site Status
Recruiting
Facility Name
Mills Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Individual Site Status
Recruiting
Facility Name
UC San Diego (UCSD) AntiViral Research Center (AVRC)
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
Optimus Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Clinical and Translational Research Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale University; School of Medicine; AIDS Program
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
Midland Florida Clinical Research Center, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Name
Can Community Health Care
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Individual Site Status
Recruiting
Facility Name
Midway Immunology and Research Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
Triple O Research Institute, P.A.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University Hospital Midtown Infectious Disease Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Name
Infectious Disease Specialists of Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Recruiting
Facility Name
Be Well Medical Center
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Individual Site Status
Recruiting
Facility Name
Southhampton Healthcare, Inc
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
Individual Site Status
Recruiting
Facility Name
ID Care, P.A.
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Individual Site Status
Recruiting
Facility Name
AXCES Research Group, LLC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Health Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Regional Center for Infectious Disease Research
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Individual Site Status
Recruiting
Facility Name
The Brody School of Medicine at East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Individual Site Status
Recruiting
Facility Name
Rosedale Health and Wellness
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Name
Prisma Health - Clinical Research Unit
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Name
St Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
AIDS Arms, Inc. DBA Prism Health North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Individual Site Status
Recruiting
Facility Name
North Texas Infectious Diseases Consultant's, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
AXCES Research Group, LLC
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
Facility Name
The Crofoot Research Center, INC
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Alliance for Research & Education, Infectious Diseases LLC (CARE-ID)
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Individual Site Status
Recruiting
Facility Name
East Sydney Doctors
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Name
Holdsworth House Medical Practice
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010 NSW
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
CMU Quartier Latin Inc
City
Montreal
ZIP/Postal Code
H2L 0B1
Country
Canada
Individual Site Status
Withdrawn
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Maple Leaf Research/Maple Leaf Medical Clinic
City
Toronto
ZIP/Postal Code
M5G 1K2
Country
Canada
Individual Site Status
Recruiting
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
ZIP/Postal Code
M5G 2N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Research Puerto Rico
City
San Juan
ZIP/Postal Code
909
Country
Puerto Rico
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-536-5939
Description
Gilead Clinical Trials Website

Learn more about this trial

A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

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