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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Randomized Phase: Lenacapavir (LEN) + Teropavimab Dose A + Zinlirvimab Dose B 		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.
  • Drug: Teropavimab
    Administered intravenously
    Other names:
    • GS-5423
  • Drug: Zinlirvimab
    Administered intravenously
    Other names:
    • GS-2872
  • Drug: Lenacapavir Tablet
    Administered orally
    Other names:
    • GS-6207
  • Drug: Lenacapavir Injection
    Administered subcutaneously
    Other names:
    • GS-6207
Experimental
Randomized Phase: Antiretroviral Therapy (ART) 		Participants will continue their baseline oral ART through Week 52.
  • Drug: Antiretroviral Therapy
    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.
Experimental
Extension Phase: LEN + Teropavimab Dose A + Zinlirvimab Dose B 		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.
  • Drug: Teropavimab
    Administered intravenously
    Other names:
    • GS-5423
  • Drug: Zinlirvimab
    Administered intravenously
    Other names:
    • GS-2872
  • Drug: Lenacapavir Injection
    Administered subcutaneously
    Other names:
    • GS-6207
Experimental
Extension Phase: ART 		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.
  • Drug: Teropavimab
    Administered intravenously
    Other names:
    • GS-5423
  • Drug: Zinlirvimab
    Administered intravenously
    Other names:
    • GS-2872
  • Drug: Lenacapavir Tablet
    Administered orally
    Other names:
    • GS-6207
  • Drug: Lenacapavir Injection
    Administered subcutaneously
    Other names:
    • GS-6207

More Details

Status
Active, not recruiting
Sponsor
Gilead Sciences

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.