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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 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

590

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Compresse di lenacapavir
Somministrato per via orale
Altri nomi:
  • LEN
Droga: Lenacapavir
Administered subcutaneously
Altri nomi:
  • LEN
Droga: Teropavimab
Administered intravenously (IV)
Altri nomi:
  • GS-5423
  • TAB
Droga: Zinlirvimab
Administered IV
Altri nomi:
  • GS-2872
  • ZAB
Comparatore attivo: 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.
Droga: Cabotegravir
Administered intramuscular (IM)
Altri nomi:
  • TAXI
Droga: Rilpivirine
Administered IM
Altri nomi:
  • RPV

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
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.
Lasso di tempo: Week 52
Week 52

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gilead Sciences

Investigatori

  • Direttore dello studio: Gilead Study Director, Gilead Sciences

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 luglio 2026

Completamento primario (Stimato)

1 marzo 2029

Completamento dello studio (Stimato)

1 marzo 2033

Date di iscrizione allo studio

Primo inviato

26 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2026

Primo Inserito (Effettivo)

6 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GS-US-536-5938
  • 2025-524335-39 (Altro identificatore: European Medicines Agency)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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