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En undersøgelse til evaluering af effektiviteten af ​​langtidsvirkende (LA) Cabotegravir (CAB) + Rilpivirin (RPV) LA, når det gives til deltagere med påviselig HIV-1 (CROWN)

30. september 2026 opdateret af: ViiV Healthcare

En fase 3b, åben etiket, randomiseret, standard-of-care kontrolarm, multicenter, overlegenhedsundersøgelse, der evaluerer effektiviteten, sikkerheden og tolerabiliteten af ​​injicerbar CAB LA + RPV LA hos viremiske deltagere, der lever med HIV-1 (CROWN)

This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

326

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, 1023
        • GSK Investigational Site
      • Buenos Aires, Argentina, C1425AGC
        • GSK Investigational Site
      • Buenos Aires, Argentina, 1427
        • GSK Investigational Site
      • Capital Federal, Argentina, C1181ACH
        • GSK Investigational Site
      • Ciudad Autonoma Buenos Aires, Argentina, C1405CKC
        • GSK Investigational Site
      • Córdoba, Argentina, X5000JJS
        • GSK Investigational Site
      • Rosario, Argentina, S2000PBJ
        • GSK Investigational Site
  • Belgien
      • Antwerp, Belgien, 2000
        • GSK Investigational Site
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L 4P9
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H4A 3J1
        • GSK Investigational Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35222
        • GSK Investigational Site
    • California
      • Los Angeles, California, Forenede Stater, 90069
        • GSK Investigational Site
      • Los Angeles, California, Forenede Stater, 90036
        • GSK Investigational Site
      • Los Angeles, California, Forenede Stater, 90035
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • GSK Investigational Site
      • Denver, Colorado, Forenede Stater, 80204
        • GSK Investigational Site
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • GSK Investigational Site
    • Delaware
      • Newark, Delaware, Forenede Stater, 19711
        • GSK Investigational Site
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20017
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32209
        • GSK Investigational Site
      • Miami, Florida, Forenede Stater, 33136
        • GSK Investigational Site
      • Sarasota, Florida, Forenede Stater, 34237-3116
        • GSK Investigational Site
      • West Palm Beach, Florida, Forenede Stater, 33409
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • GSK Investigational Site
      • Decatur, Georgia, Forenede Stater, 30033
        • GSK Investigational Site
      • Macon, Georgia, Forenede Stater, 31201
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • GSK Investigational Site
      • Chicago, Illinois, Forenede Stater, 60613
        • GSK Investigational Site
      • Chicago, Illinois, Forenede Stater, 60611-2826
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • GSK Investigational Site
      • Baltimore, Maryland, Forenede Stater, 21287
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • GSK Investigational Site
    • Michigan
      • Berkley, Michigan, Forenede Stater, 48072
        • GSK Investigational Site
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • GSK Investigational Site
      • St Louis, Missouri, Forenede Stater, 63110-1035
        • GSK Investigational Site
    • New Jersey
      • Newark, New Jersey, Forenede Stater, 07102
        • GSK Investigational Site
    • New York
      • Hawthorne, New York, Forenede Stater, 10532-2140
        • GSK Investigational Site
      • New York, New York, Forenede Stater, 10032
        • GSK Investigational Site
      • New York, New York, Forenede Stater, 10010
        • GSK Investigational Site
      • The Bronx, New York, Forenede Stater, 10467
        • GSK Investigational Site
      • The Bronx, New York, Forenede Stater, 10468-3904
        • GSK Investigational Site
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27401-1209
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • GSK Investigational Site
      • Columbus, Ohio, Forenede Stater, 43210
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75246-2004
        • GSK Investigational Site
      • Houston, Texas, Forenede Stater, 77030
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, Forenede Stater, 98104-2420
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53212
        • GSK Investigational Site
  • Italien
      • Bari, Italien
        • GSK Investigational Site
      • Bergamo, Italien, 24127
        • GSK Investigational Site
      • Milan, Italien, 20142
        • GSK Investigational Site
      • Milan, Italien, 20127
        • GSK Investigational Site
      • Roma, Italien, 00149
        • GSK Investigational Site
  • Portugal
      • Porto, Portugal, 4099-001
        • GSK Investigational Site
      • Porto, Portugal, 4200-319
        • GSK Investigational Site
  • Spanien
      • Barcelona, Spanien, 08036
        • GSK Investigational Site
      • Barcelona, Spanien, 08035
        • GSK Investigational Site
      • Barcelona, Spanien, 08003
        • GSK Investigational Site
      • Barcelona, Spanien, 08026
        • GSK Investigational Site
      • Córdoba, Spanien, 14004
        • GSK Investigational Site
      • Madrid, Spanien, 28041
        • GSK Investigational Site
      • Madrid, Spanien, 28006
        • GSK Investigational Site
      • Madrid, Spanien, 28007
        • GSK Investigational Site
      • Madrid, Spanien, 28040
        • GSK Investigational Site
      • Madrid, Spanien, 28046
        • GSK Investigational Site
      • Madrid, Spanien, 28034
        • GSK Investigational Site
      • Madrid, Spanien, 28031
        • GSK Investigational Site
      • Madrid, Spanien, 28020
        • GSK Investigational Site
      • Murcia, Spanien, 30120
        • GSK Investigational Site
      • Málaga, Spanien, 29010
        • GSK Investigational Site
      • Málaga, Spanien, 29530
        • GSK Investigational Site
      • Palma de Mallorca, Spanien, 07120
        • GSK Investigational Site
      • Sabadell Barcelona, Spanien, 08208
        • GSK Investigational Site
      • Seville, Spanien, 41013
        • GSK Investigational Site
      • Vigo Pontevedra, Spanien, 36312
        • GSK Investigational Site
      • Zaragoza, Spanien, 50009
        • GSK Investigational Site
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
        • GSK Investigational Site
    • Bizkaia
      • Bilbao, Bizkaia, Spanien, 48013
        • GSK Investigational Site
    • Cádiz
      • Puerto Real, Cádiz, Spanien, 11510
        • GSK Investigational Site
  • Tyskland
      • Berlin, Tyskland, 10439
        • GSK Investigational Site
      • Cologne, Tyskland, 50668
        • GSK Investigational Site
      • Frankfurt, Tyskland, 60596
        • GSK Investigational Site
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Tyskland, 50674
        • GSK Investigational Site
      • Düsseldorf, North Rhine-Westphalia, Tyskland, 40225
        • GSK Investigational Site

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

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age

    1. Aged >=12 years and >=35 kg (at the time of obtaining informed consent).

  • Type of Participant and Disease Characteristics 2.HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL.

    3.Plasma HIV-1 RNA >1 000 c/mL and greater than (<) 100 000 c/mL at Screening. 4.Evidence of insufficient virologic response to participant's current oral ART regimen within 18 months prior to study entry according to at least 1 of the following criteria: i.<1 log10 decrease in HIV-1 RNA or HIV-1 RNA >200 c/mL at 2 time points at least 4 weeks apart in individuals who have been prescribed oral ART for at least 3 consecutive months.

ii. Documented lapse in current oral ART regimen usage expected to result in HIV-1 viremia (defined as at least a 30-day consecutive period of non-use of oral ART) iii. Documented need for change from oral ART regimen that investigator attributes as primary reason for insufficient virologic response (e.g., safety findings and/or limited tolerability, clinically relevant DDIs).

Currently being treated with an oral ART regimen specific regimen to be recorded at Screening, and willing to continue taking that regimen until approximately 1 week after the Month 6 visit.

  • Pregnancy, Sex and Contraceptive/Barrier Requirements 5. Person of childbearing potential (POCBP) must have a negative serum or urine pregnancy test at screening and on Day 1.

  • Informed Consent/Assent 6.Informed consent/Assent must be provided as follows:

    1. Adult participants (>=18 years old) must be capable of giving signed informed consent as described in the full study protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and stated in the full study protocol.
    2. For adolescent participants (12 to <18 years of age at screening), the parent(s) or legal guardian must be capable of giving signed informed consent.

Exclusion Criteria:

• Medical Conditions

  1. HIV-1 Subtype A6, if known from historical result.

  2. Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study.

  3. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones).

  4. Individuals with both HIV and Hepatitis B virus (HBV) will be excluded from participating in studies where they would not be able to receive appropriate therapy for their HBV co-infection and therefore may be at risk of hepatitis B flare. Exclusion will be determined by evidence of HBV infection based on the results of testing at Screening for HBsAg, HBcAb, HBsAb and HBV.

  5. History of liver cirrhosis with or without hepatitis viral co-infection.

  6. Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.

  7. Participants with HCV co-infection will be excluded entry into this study if they are currently receiving anti-HCV therapy at baseline (Day 1).

  8. Participants determined by the investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder.

  9. History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.

  10. Participants who in the investigator's judgment, pose a significant suicidality risk. Participant's history of suicidal behaviour and/or suicidal ideation should be considered when evaluating for suicide risk.

  11. Any pre-existing physical or mental condition which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.

    • Prior/Concomitant Therapy

  12. Any previous use of CAB.

  13. Current or anticipated need for chronic anti-coagulants.

  14. Use of concomitant medications which are associated with Torsades de Pointes (TdP).

  15. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.

  16. Treatment with any of the following agents within 28 days of Screening:

    1. radiation therapy;
    2. cytotoxic chemotherapeutic agents;
    3. tuberculosis therapy with the exception of isoniazid;
    4. anti-coagulation agents, with the exception of the use of low dose acetylsalicylic acid (<=325mg);
    5. immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons.

  17. Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational medicinal product (IP).

  18. Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.

    • Prior/Concurrent Clinical Study Experience

  19. Participant is currently participating in, or anticipates being selected for, any other interventional study.

    • Diagnostic assessments

  20. Any evidence of viral drug resistance based on the presence of any major RAM to INSTIs or NNRTIs in the Screening result; or, if known, in any historical resistance test result.

  21. Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.

  22. Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. A single repeat test is allowed during the Screening period to verify a result.

  23. ALT >=5 times ULN or ALT >=3×ULN and bilirubin >=1.5×ULN (with >35% direct bilirubin).

  24. eGFR of <30 mL/min/1.73 m2 via refitted, race-neutral CKD-EPIcr_R method (adult participants) or <50 mL/min/1.73 m2 using the Bedside Schwartz equation (adolescent participants).

  25. Hemoglobin <9.0 g/dL.

  26. Corrected QT interval (QTc >450 msec or QTc >480 msec for participants with bundle branch block, calculated using ECGs performed in triplicate).

    • Other exclusions

  27. Unwilling to receive injections, or unable to receive gluteal injections.

  28. The participant has gluteal implants or prosthesis; or a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reaction (ISRs).

  29. Evidence of alcohol or substance use disorder within the previous 12 months, using standard methods for their site, that would interfere with the participant's safety.

  30. Adolescents who are wards of the state or government. To assess any potential impact on participant eligibility with regard to safety, the investigator must refer to the Investigator's brochure (IB) and supplements, approved product labels, and/or local prescribing information for detailed information regarding warnings, precautions, contraindications, AEs, drug interactions, and other significant data pertaining to the study drugs.

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: CAB LA + RPV LA Group

Participants receive initial injections at Day 1 and Month 1, followed by maintenance injections every 2 months for up to 24 months.
Medicin: CAB LA + RPV LA

Intramuscular injection administered monthly for first 2 initiation doses then every 2 months.
Aktiv komparator: Oral ART Control Group

Participants continue to take their current oral ART for 6 months, including a final dose at their first injection visit.
Medicin: Oral ART

Oral medication provided to participants by the site/their regular healthcare professional (HCP) as part of their standard of care (SOC) treatment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants with virologic suppression after the CAB LA + RPV LA treatment compared to oral ART
Tidsramme: At Month 6

A virologic suppression is defined by HIV-1 RNA less than (<) 50 copies (c)/mL.
At Month 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tid til virologisk suppression
Tidsramme: Fra baseline (dag 1) op til måned 6
Fra baseline (dag 1) op til måned 6
Antal deltagere med behandlingsfremkaldte resistensassocierede mutationer (RAM'er)
Tidsramme: Fra baseline (dag 1) op til måned 6
Fra baseline (dag 1) op til måned 6
Antal deltagere med behandlingsfremkaldte RAM'er
Tidsramme: Op til 12. og 24. måned
Op til 12. og 24. måned
Antal dødsfald
Tidsramme: Op til måned 6, måned 12 og måned 24
Op til måned 6, måned 12 og måned 24
Antal AE'er, der fører til seponering
Tidsramme: Op til måned 6, måned 12 og måned 24
Op til måned 6, måned 12 og måned 24
Time to treatment related discontinuation (=Failure) (TRDF)
Tidsramme: From Baseline (Day 1) up to Month 6

TRDF can be caused by a confirmed virologic failure or a drug-related adverse event (AE), intolerability of injections, protocol defined stopping criteria or lack of efficacy.
From Baseline (Day 1) up to Month 6
Number of participants with confirmed protocol-defined virologic failure (VF)
Tidsramme: From Baseline (Day 1) up to Month 6

VF is defined as: confirmed plasma HIV-1 RNA levels greater than or equal to (>=) 400 c/mL on or after Month 4; confirmed rebound in plasma HIV-1 RNA levels to >=400 c/mL after prior confirmed suppression to <400 c/mL; confirmed plasma HIV-1 RNA levels greater than (>) 1 log10 c/mL above the nadir value where nadir is >=400 c/mL; decrease in plasma HIV-1 RNA of <1 log10 c/mL by Month 1, with subsequent. confirmation, and resistance emergence to ARVs (unless plasma HIV-1 RNA is. <400 c/mL).
From Baseline (Day 1) up to Month 6
Number of participants with serious adverse events (SAEs)
Tidsramme: Up to Month 6, Month 12, and Month 24

A SAE is defined as any untoward medical occurrence that, at any dose, meets one or. more of the following criteria: results in death, is life threatening, requires inpatient hospitalization (or prolongation of existing hospitalization), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes and other significant medical events deemed so by the investigator.
Up to Month 6, Month 12, and Month 24
Number of participants with Grade 2 to 5 drug-related adverse events (AEs)
Tidsramme: Up to Month 6, Month 12, and Month 24

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not. considered related to the study intervention. Every AE is graded according to the DAIDS toxicity scales. Grade 2 = moderate symptoms, Grade 3 = severe symptoms, Grade 4 = Potentially life-threatening. symptoms and Grade 5 = death.
Up to Month 6, Month 12, and Month 24

Samarbejdspartnere og efterforskere

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

Sponsor

ViiV Healthcare

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)

2. december 2024

Primær færdiggørelse (Faktiske)

19. august 2026

Studieafslutning (Anslået)

9. juni 2028

Datoer for studieregistrering

Først indsendt

15. november 2024

Først indsendt, der opfyldte QC-kriterier

15. november 2024

Først opslået (Faktiske)

19. november 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 221611
  • 2024-515070-28-00 (Anden identifikator: EU CT)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Study sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf.

IPD-delingstidsramme

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD-delingsadgangskriterier

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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 .

Abonner