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Trial record 1 of 1 for:    GS-US-536-5816 | HIV
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Study to Evaluate the Safety and Efficacy of GS-5423 and GS-2872 in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection

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ClinicalTrials.gov Identifier: NCT04811040
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE March 19, 2021
First Posted Date  ICMJE March 23, 2021
Last Update Posted Date December 17, 2021
Actual Study Start Date  ICMJE April 8, 2021
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2021)
Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) [ Time Frame: First dose date up to Week 26 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2021)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Proportion of Participants With Positive Anti-GS-5423 Antibodies [ Time Frame: Week 26 ]
  • Proportion of Participants With Positive Anti-GS-5423 Antibodies [ Time Frame: Week 52 ]
  • Proportion of Participants With Positive Anti-GS-2872 Antibodies [ Time Frame: Week 26 ]
  • Proportion of Participants With Positive Anti-GS-2872 Antibodies [ Time Frame: Week 52 ]
  • Change from Baseline in CD4+ Cell Count at Week 26 [ Time Frame: Baseline; Week 26 ]
  • Change from Baseline in CD4+ Cell Count at Week 52 [ Time Frame: Baseline; Week 52 ]
  • Proportion of Participants Who Develop Treatment-Emergent Resistance to Lenacapvir (LEN), GS-5423, and GS-2872 [ Time Frame: Day 1 up to Week 52 ]
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) [ Time Frame: First dose date up to Week 26 ]
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) [ Time Frame: First dose date up to Week 52 ]
  • Percentage of Participants Experiencing Treatment-Emergent Severe Adverse Events (SAEs) [ Time Frame: First dose date up to Week 52 ]
  • Pharmacokinetic (PK) Parameter: AUC0-t of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    AUC0-t is defined as the concentration of drug over time from time zero to time "t".
  • PK Parameter: AUClast of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    AUClast is defined as the concentration of drug from time zero to the last observable concentration.
  • PK Parameter: T1/2 of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    T1/2 is defined as the estimate of the terminal elimination half-life of the drug.
  • PK Parameter: Cmax of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    Cmax is defined as the maximum observed concentration of drug.
  • PK Parameter: Tmax of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    Tmax is defined as the time (observed time point) of Cmax.
  • PK Parameter: Tlast of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    Tlast is defined as the time (observed time point) of Clast (the last observable concentration of drug).
  • PK Parameter: Ct of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    Ct is the concentration at a particular time (t).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2021)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Proportion of Participants With Positive Anti-GS-5423 Antibodies [ Time Frame: Day 1 up to Week 52 ]
  • Proportion of Participants With Positive Anti-GS-2872 Antibodies [ Time Frame: Day 1 up to Week 52 ]
  • Change from Baseline in CD4+ Cell Count at Week 26 [ Time Frame: Baseline; Week 26 ]
  • Change from Baseline in CD4+ Cell Count at Week 52 [ Time Frame: Baseline; Week 52 ]
  • Proportion of Participants Who Develop Resistance to Lenacapvir (LEN), GS-5423, and GS-2872 [ Time Frame: Day 1 up to Week 52 ]
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) [ Time Frame: First dose date up to Week 52 ]
  • Pharmacokinetic (PK) Parameter: AUC0-t of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    AUC0-t is defined as the concentration of drug over time from time zero to time "t".
  • PK Parameter: AUClast of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    AUClast is defined as the concentration of drug from time zero to the last observable concentration.
  • PK Parameter: T1/2 of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    T1/2 is defined as the estimate of the terminal elimination half-life of the drug.
  • PK Parameter: Cmax of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    Cmax is defined as the maximum observed concentration of drug.
  • PK Parameter: Tmax of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    Tmax is defined as the time (observed time point) of Cmax.
  • PK Parameter: Tlast of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    Tlast is defined as the time (observed time point) of Clast (the last observable concentration of drug).
  • PK Parameter: Ct of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    Ct is the concentration at a particular time (t).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of GS-5423 and GS-2872 in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection
Official Title  ICMJE A Phase 1b Randomized, Blinded, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection
Brief Summary The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) GS-5423 and GS-2872 in combination with the HIV capsid inhibitor lenacapavir (LEN).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Clinical pharmacologist and sponsor are not masked to treatment assignment.
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection
Intervention  ICMJE
  • Drug: Oral Lenacapavir
    Tablets administered without regard to food
    Other Name: GS-6207
  • Drug: Subcutaneous Lenacapavir
    Administered in the abdomen via subcutaneous injections
    Other Name: GS-6207
  • Drug: GS-5423
    Administered intravenously
    Other Name: 3BNC117-LS
  • Drug: GS-2872
    Administered intravenously
    Other Name: 10-1074-LS
Study Arms  ICMJE
  • Experimental: Lenacapavir (LEN), GS-5423, GS-2872 Dose C
    Participants will begin treatment by receiving LEN Dose A + LEN Dose B + GS-5423 + GS-2872 Dose C followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + GS-5423 + GS-2872 Dose C.
    Interventions:
    • Drug: Oral Lenacapavir
    • Drug: Subcutaneous Lenacapavir
    • Drug: GS-5423
    • Drug: GS-2872
  • Experimental: LEN, GS-5423, GS-2872 Dose D
    Participants will begin treatment by receiving LEN Dose A + LEN Dose B + GS-5423 + GS-2872 Dose D followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + GS-5423 + GS-2872 Dose D.
    Interventions:
    • Drug: Oral Lenacapavir
    • Drug: Subcutaneous Lenacapavir
    • Drug: GS-5423
    • Drug: GS-2872
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2021)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • On first-line antiretroviral therapy (ART) for ≥ 2 years prior to screening. A change in ART regimen ≥ 28 days prior to screening for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed
  • No documented historical resistance to the current ART regimen
  • Plasma HIV-1 RNA < 50 copies/mL at screening
  • Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 18 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable.
  • Proviral phenotypic sensitivity to both GS-5423 and GS-2872 at screening
  • CD4+ count nadir ≥ 350 cells/μL
  • Screening CD4+ count ≥ 500 cells/μL
  • Availability of a fully active alternative ART regimen, in the opinion of the investigator, in the event of discontinuation of the current ART regimen with development of resistance

Key Exclusion Criteria:

  • Comorbid condition requiring ongoing immunosuppression
  • Evidence of current hepatitis B virus (HBV) infection
  • Evidence of current hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable)
  • History of opportunistic infection or illness indicative of Stage 3 HIV disease

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04811040
Other Study ID Numbers  ICMJE GS-US-536-5816
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP