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Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

13. august 2026 opdateret af: Gilead Sciences

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment.

The primary objective of this study are to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

590

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
    • New South Wales
      • Surry Hills, New South Wales, Australien, 2010
        • Rekruttering
        • Taylor Square Private Clinic
      • Sydney, New South Wales, Australien, 2010
        • Rekruttering
        • East Sydney Doctors
  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94102
        • Rekruttering
        • Optimus Medical Group
    • Florida
      • DeLand, Florida, Forenede Stater, 32720
        • Rekruttering
        • Midland Florida Clinical Research Center, LLC
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • Rekruttering
        • CAN Community Health Fort Lauderdale
      • Ft. Pierce, Florida, Forenede Stater, 34982
        • Rekruttering
        • Midway Immunology and Research Center
      • Miami Gardens, Florida, Forenede Stater, 33055
        • Rekruttering
        • CAN Community Health Miami Gardens
      • Orlando, Florida, Forenede Stater, 32803
        • Rekruttering
        • BLISS Health Inc.
      • Tampa, Florida, Forenede Stater, 33614
        • Rekruttering
        • MOORE Clinical Research, Inc d/b/a TrueBlue Clinical Research
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Rekruttering
        • Triple O Research Institute, P.A.
      • West Palm Beach, Florida, Forenede Stater, 33409
        • Rekruttering
        • Atlantic Clinical Research Institute
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309
        • Rekruttering
        • Atlanta ID Group, PC
      • Savannah, Georgia, Forenede Stater, 31401
        • Rekruttering
        • Chatham County Health Department
    • Michigan
      • Berkley, Michigan, Forenede Stater, 48072
        • Rekruttering
        • Be Well Medical Center
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Rekruttering
        • KC Care Health Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
        • Rekruttering
        • North Texas Infectious Diseases Consultants, P.A.
    • Virginia
      • Annandale, Virginia, Forenede Stater, 22003
        • Rekruttering
        • Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Rekruttering
        • TribalMed PLLC
  • Japan
      • Osaka, Japan, 540-0006
        • Rekruttering
        • National Hospital Organization Osaka National Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Key Inclusion Criteria:

  • Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria:

    1) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at screening.

  • At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). A single virologic elevation of ≥ 50 copies/mL and < 400 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable if the subsequent plasma HIV-1 RNA level is < 50 copies/mL.

  • A plasma HIV-1 RNA test < 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) within the last 6 months prior to screening.

    1) If > 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all must be < 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).

  • On a stable oral ARV therapy (ART) for ≥ 6 months prior to screening.

    1. A change in ART regimen ≥ 3 months prior to the screening visit for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed; individuals with a change in ART regimen ≥ 3 months prior to screening must have been on the regimen for ≥ 3 months prior to screening, and all HIV-1 RNA measurements in that period must be < 50 copies/mL. There are no permitted changes to ART regimens between screening and Day 1.

Key Exclusion Criteria:

  • History of an opportunistic infection or illness indicative of Stage 3 HIV disease.
  • History of treatment failure.

  • Known or suspected resistance to either CAB or RPV.

    1. Resistance to CAB defined as the following mutations: G118R, Q148K, Q148R, T66K+L74M, E92Q+N155H, E138A+Q148R, E138K+Q148K/R, G140C+Q148R, G140S+Q148H/K/R, Y143H+N155H, and Q148R+N155H.
    2. Resistance to RPV defined as the following mutations: K101E and P; E138A, G, K, R, and Q; V179L; Y181C, I, and V; Y188L; H221Y; F227C; M230I and L, and the combination of L100I/K103N.
  • Individuals with a dermatologic condition or implanted prothesis overlying the gluteal injection site for CAB + RPV.
  • Known hypersensitivity to the study intervention, its metabolites, or formulation excipients.
  • Active, serious infections (other than HIV-1) requiring therapy < 30 days prior to randomization.
  • Active tuberculosis infection.
  • Acute hepatitis of any cause < 30 days before randomization.
  • History of, or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or severe hepatic impairment (Child-Pugh Class C).
  • Active malignancy requiring acute systemic therapy.
  • Have poor venous access that would limit phlebotomy or intravenous (IV) infusion of study drugs.
  • Prior use of, or exposure to, LEN or a broadly neutralizing antibody (bNAb) for HIV-1.
  • Prior use of, or exposure to, long-acting (LA) injectable CAB or LA injectable RPV.
  • Prior use of, or exposure to, ibalizumab, fostemsavir, or maraviroc.
  • Baseline regimen consisting of monotherapy with any single antiretroviral (ARV).
  • Treatment with immunosuppressant therapies (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) within 4 weeks of screening (with the exception of a single short course of corticosteroids lasting ≤ 7 days) or have a comorbid condition with an anticipated need ongoing immunosuppressive treatment during the study.
  • Hepatitis C virus (HCV) antibody positive and HCV RNA detectable.

  • Chronic hepatitis B virus (HBV) infection, as determined by either:

    1. Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.
    2. Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
  • Severe renal impairment-estimated glomerular filtration rate < 30 mL/min according to the Cockcroft-Gault formula.
  • Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant, as determined by the investigator.

  • Any of the following laboratory values at screening:

    1. Alanine aminotransferase > 5 x upper limit of normal (ULN).
    2. Direct bilirubin > 1.5 x ULN.
    3. Platelets < 50,000/mm^3.
    4. Hemoglobin < 8.0 g/dL.

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment Group 1: Lenacapavir(LEN)+ Teropavimab(TAB)+ Zinlirvimab (ZAB)

Participants will receive oral LEN 600 mg, subcutaneous (SC) LEN 927 mg, and intravenously (IV) infusions of TAB and ZAB on Day 1. Participants will self-administer oral LEN 600 mg on Day 2. Every 26 weeks, participants will receive SC LEN and IV infusions of TAB and ZAB up to Week 92.

After Week 92, eligible participants will have an option to continue LEN + TAB + ZAB in the extension phase, until completion of the extension phase, permanently discontinuing the extension phase or the extension is discontinued at the sponsor's sole discretion, whichever occurs first.
Medicin: Lenacapavir tablet
Indgives oralt
Andre navne:
  • LEN
Medicin: Lenacapavir
Administered subcutaneously
Andre navne:
  • LEN
Medicin: Teropavimab
Administered intravenously (IV)
Andre navne:
  • GS-5423
  • TAB
Medicin: Zinlirvimab
Administered IV
Andre navne:
  • GS-2872
  • ZAB
Aktiv komparator: Treatment Group 2: Cabotegravir (CAB) + Rilpivirine (RPV)

Participants will discontinue their baseline oral antiretroviral therapy (ART) and will receive intramuscular (IM) CAB 600 mg + RPV 900 mg on Day 1, Week 4 and then every 8 weeks for up to 92 weeks.

After Week 92, eligible participants will have an option to continue LEN + TAB + ZAB in the extension phase, until completion of the extension phase, permanently discounting the extension phase or the extension is discontinued at the sponsor's sole discretion, whichever occurs first.
Medicin: Cabotegravir
Administered intramuscular (IM)
Andre navne:
  • CAB
Medicin: Rilpivirine
Administered IM
Andre navne:
  • RPV

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of Participants With HIV-1 ribonucleic acid (RNA) ≥ 50 Copies/mL at Week 52 as Defined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm.
Tidsramme: Week 52
Week 52

Sekundære resultatmål

Resultatmål
Tidsramme
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 92 as Defined by the US FDA Snapshot Algorithm.
Tidsramme: Week 92
Week 92
Trough Concentrations for LEN, TAB, and ZAB at Week 26
Tidsramme: Week 26
Week 26
Trough Concentrations for LEN, TAB, and ZAB at Week 52
Tidsramme: Week 52
Week 52
Trough Concentrations for LEN, TAB, and ZAB at Week 104
Tidsramme: Week 104
Week 104
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
Tidsramme: Week 52
Week 52
Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 92 as Determined by the US FDA Snapshot Algorithm.
Tidsramme: Week 92
Week 92
Change From Baseline in clusters of differentiation 4 (CD4) (CD4)+ T-cell Counts at Week 52
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in CD4+ T-cell Counts at Week 92
Tidsramme: Baseline, Week 92
Baseline, Week 92
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Tidsramme: Up to Week 92
Up to Week 92
Percentages of Participants Prematurely Discontinuing Their Study Treatment due to an AE
Tidsramme: Up to Week 92
Up to Week 92
Percentages of Participants With Antidrug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) of TAB
Tidsramme: Up to 92 Weeks
Up to 92 Weeks
Percentages of Participants With of ADAs and NAbs of ZAB
Tidsramme: Up to 92 Weeks
Up to 92 Weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gilead Sciences

Efterforskere

  • Studieleder: Gilead Study Director, Gilead Sciences

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. juli 2026

Primær færdiggørelse (Anslået)

1. marts 2029

Studieafslutning (Anslået)

1. marts 2033

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GS-US-536-5938
  • 2025-524335-39 (Anden identifikator: European Medicines Agency)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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