The trial is taking place at:
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Clinical Research Puerto Rico | San Juan, PR

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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

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Gilead Sciences

Status and phase

Active, not recruiting
Phase 2

Conditions

HIV Infections

Treatments

Drug: Antiretroviral Therapy
Drug: Zinlirvimab
Drug: Lenacapavir Injection
Drug: Teropavimab
Drug: Lenacapavir Tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT05729568
GS-US-536-5939

Details and patient eligibility

About

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.

Enrollment

83 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

83 participants in 4 patient groups

Randomized Phase: Lenacapavir (LEN) + Teropavimab Dose A + Zinlirvimab Dose B
Experimental group
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.
Treatment:
Drug: Lenacapavir Tablet
Drug: Lenacapavir Injection
Drug: Teropavimab
Drug: Zinlirvimab
Randomized Phase: Antiretroviral Therapy (ART)
Experimental group
Description:
Participants will continue their baseline oral ART through Week 52.
Treatment:
Drug: Antiretroviral Therapy
Extension Phase: LEN + Teropavimab Dose A + Zinlirvimab Dose B
Experimental group
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.
Treatment:
Drug: Lenacapavir Injection
Drug: Teropavimab
Drug: Zinlirvimab
Extension Phase: ART
Experimental group
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.
Treatment:
Drug: Lenacapavir Tablet
Drug: Lenacapavir Injection
Drug: Teropavimab
Drug: Zinlirvimab

Trial contacts and locations

36

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Central trial contact

Gilead Clinical Study Information Center

Data sourced from clinicaltrials.gov

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