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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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

590

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Lenacapavir tablett
Administrert oralt
Andre navn:
  • LEN
Legemiddel: Lenacapavir
Administered subcutaneously
Andre navn:
  • LEN
Legemiddel: Teropavimab
Administered intravenously (IV)
Andre navn:
  • GS-5423
  • TAB
Legemiddel: Zinlirvimab
Administered IV
Andre navn:
  • 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.
Legemiddel: Cabotegravir
Administered intramuscular (IM)
Andre navn:
  • DROSJE
Legemiddel: Rilpivirine
Administered IM
Andre navn:
  • RPV

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gilead Sciences

Etterforskere

  • Studieleder: Gilead Study Director, Gilead Sciences

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. juli 2026

Primær fullføring (Antatt)

1. mars 2029

Studiet fullført (Antatt)

1. mars 2033

Datoer for studieregistrering

Først innsendt

26. juni 2026

Først innsendt som oppfylte QC-kriteriene

26. juni 2026

Først lagt ut (Faktiske)

6. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

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