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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 augusti 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

590

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Lenacapavir tablett
Administreras oralt
Andra namn:
  • LEN
Läkemedel: Lenacapavir
Administered subcutaneously
Andra namn:
  • LEN
Läkemedel: Teropavimab
Administered intravenously (IV)
Andra namn:
  • GS-5423
  • TAB
Läkemedel: Zinlirvimab
Administered IV
Andra namn:
  • 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.
Läkemedel: Cabotegravir
Administered intramuscular (IM)
Andra namn:
  • CAB
Läkemedel: Rilpivirine
Administered IM
Andra namn:
  • RPV

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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.
Tidsram: Week 52
Week 52

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Gilead Sciences

Utredare

  • Studierektor: Gilead Study Director, Gilead Sciences

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

14 juli 2026

Primärt slutförande (Beräknad)

1 mars 2029

Avslutad studie (Beräknad)

1 mars 2033

Studieregistreringsdatum

Först inskickad

26 juni 2026

Först inskickad som uppfyllde QC-kriterierna

26 juni 2026

Första postat (Faktisk)

6 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • GS-US-536-5938
  • 2025-524335-39 (Annan identifierare: European Medicines Agency)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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