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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 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

590

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Lenacapavir-tablet
Oraal toegediend
Andere namen:
  • LEN
Geneesmiddel: Lenacapavir
Administered subcutaneously
Andere namen:
  • LEN
Geneesmiddel: Teropavimab
Administered intravenously (IV)
Andere namen:
  • GS-5423
  • TAB
Geneesmiddel: Zinlirvimab
Administered IV
Andere namen:
  • GS-2872
  • ZAB
Actieve vergelijker: 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.
Geneesmiddel: Cabotegravir
Administered intramuscular (IM)
Andere namen:
  • TAXI
Geneesmiddel: Rilpivirine
Administered IM
Andere namen:
  • RPV

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
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.
Tijdsspanne: Week 52
Week 52

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Gilead Sciences

Onderzoekers

  • Studie directeur: Gilead Study Director, Gilead Sciences

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 juli 2026

Primaire voltooiing (Geschat)

1 maart 2029

Studie voltooiing (Geschat)

1 maart 2033

Studieregistratiedata

Eerst ingediend

26 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2026

Eerst geplaatst (Werkelijk)

6 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

13 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GS-US-536-5938
  • 2025-524335-39 (Andere identificatie: European Medicines Agency)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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