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A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed

13. august 2026 oppdatert av: ViiV Healthcare

A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART

This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

564

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1425AGC
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      • Buenos Aires, Argentina, C1023AAB
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          • Veronica Lacal Ridilenir
      • Buenos Aires, Argentina, 1427
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      • Ciudad Autonoma Buenos Aires, Argentina, C1405CKC
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          • Ezequiel Cordova
      • Ciudad Autonoma Buenos Aires, Argentina, C1425AWK
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          • Gustavo Lopardo
      • Córdoba, Argentina, X5000JJS
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          • Marcelo Martins
      • Rosario, Argentina, 2000
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      • San Miguel de Tucumán, Argentina, T4000IHE
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  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
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      • Sydney, New South Wales, Australia, 2010
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    • Queensland
      • Taringa, Queensland, Australia, 4068
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    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2T1
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    • Ontario
      • Toronto, Ontario, Canada, M5G 1K2
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      • Montreal, Quebec, Canada, H2L 4E9
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      • Montreal, Quebec, Canada, H2L 4P9
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  • Forente stater
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      • Phoenix, Arizona, Forente stater, 85015
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          • Douglas Cunningham
    • California
      • Bakersfield, California, Forente stater, 93301
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          • Franco Felizarta
      • Los Angeles, California, Forente stater, 90027
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          • William Towner
      • Los Angeles, California, Forente stater, 90036
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          • Peter Ruane
      • San Diego, California, Forente stater, 92103
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          • Timothy Wilkin
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06510
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    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20017
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          • Theo Hodge
    • Florida
      • DeLand, Florida, Forente stater, 32720
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          • Godson Oguchi
      • Fort Lauderdale, Florida, Forente stater, 33316
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          • Michael Sension
      • Ft. Pierce, Florida, Forente stater, 34982
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          • Moti Ramgopal
      • Miami, Florida, Forente stater, 33136
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          • Charles Mitchell
      • Orlando, Florida, Forente stater, 32803
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          • Charlotte-Paige Rolle
      • Pensacola, Florida, Forente stater, 32503
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          • Mitchell Whitehead
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      • Vero Beach, Florida, Forente stater, 32960
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          • Gerald Pierone
      • West Palm Beach, Florida, Forente stater, 33409
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      • West Palm Beach, Florida, Forente stater, 33407
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    • Georgia
      • Decatur, Georgia, Forente stater, 30033
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    • Michigan
      • Grosse Pointe Woods, Michigan, Forente stater, 48236
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      • Santa Fe, New Mexico, Forente stater, 87505
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    • New York
      • Stony Brook, New York, Forente stater, 11794
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      • Syracuse, New York, Forente stater, 13057
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          • Elizabeth Asiago-Reddy
    • North Carolina
      • Greensboro, North Carolina, Forente stater, 27401
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    • Ohio
      • Columbus, Ohio, Forente stater, 43210
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    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
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    • Texas
      • Austin, Texas, Forente stater, 78705
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      • Dallas, Texas, Forente stater, 75246
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          • Christopher Bettacchi
      • Dallas, Texas, Forente stater, 75219
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          • Marc Tribble
      • El Paso, Texas, Forente stater, 79902
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          • Ogechika Alozie
      • Houston, Texas, Forente stater, 77098
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          • Gordon Crofoot, Jr., MD
    • Utah
      • Salt Lake City, Utah, Forente stater, 84102
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    • Virginia
      • Lynchburg, Virginia, Forente stater, 24501
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          • Joseph Saabiye
    • Washington
      • Seattle, Washington, Forente stater, 98104
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  • Japan
      • Aichi, Japan, 460-0001
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          • Yoshiyuki Yokomaku
      • Kanagawa, Japan, 221-0855
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          • Yukihiro Yoshimura
      • Osaka, Japan, 540-0006
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          • Dai Watanabe
      • Tokyo, Japan, 162-8655
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          • Hiroyuki Gatanaga
      • Tokyo, Japan, 108-8639
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          • Eisuke Adachi
      • Tokyo, Japan, 113-8677
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  • Mexico
      • Guadajalara, Mexico, 44280
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          • Luz Alicia Gonzalez-Hernandez
      • Mexico City, Mexico, 06760
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      • Mexico City, Mexico, 14080
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          • Alvaro Lopez Iñiguez
      • Mérida, Mexico, 97070
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    • Nuevo León
      • San Pedro Garza García, Nuevo León, Mexico, 66260
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      • San Juan, Puerto Rico, 00909
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  • Spania
      • Alicante, Spania, 03010
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      • Badalona, Spania, 08005
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          • Anna Bonjoch Badia
      • Barcelona, Spania, 08035
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      • Barcelona, Spania, 08036
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      • Barcelona, Spania, 08026
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          • Paula Prieto
      • Barcelona, Spania, 8907
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          • Arkaitz Imaz Vacas
      • Burgos, Spania, 09006
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          • Luis Buzon
      • Cartagena Murcia, Spania, 30202
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          • Francisco Jesús Vera Méndez
      • Córdoba, Spania, 14004
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          • Ignacio Pérez Valero
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      • Elche Alicante, Spania, 03203
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      • Madrid, Spania, 28031
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          • Guillermo Cuevas Tascon
      • Madrid, Spania, 28046
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          • Maria Luisa Montes Ramirez
      • Madrid, Spania, 28034
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          • Sergio Serrano Villar
      • Madrid, Spania, 28040
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          • Vicente Estrada
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      • Madrid, Spania, 28041
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          • Rafael Rubio
      • Madrid, Spania, 28007
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          • Cristina Diez Romero
      • Madrid, Spania, 28224
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          • Alberto Díaz de Santiago
      • Sabadell Barcelona, Spania, 08208
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          • Marta Navarro Vilasaró
      • Seville, Spania, Sevilla
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          • Juan Macias
      • Valencia, Spania, 46014
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          • Miguel García Deltoro
      • Vigo Pontevedra, Spania, 36312
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          • Antonio Ocampo Hermidia
  • Storbritannia
      • Birmingham, Storbritannia, B9 5SS
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          • Steve Taylor
      • London, Storbritannia, W2 1NY
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          • Caroline Foster
      • London, Storbritannia, WC1E 6JB
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          • Sarah Pett
      • London, Storbritannia, SW10 9NH
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          • Ruth Byrne
      • London, Storbritannia, E1 1FR
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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

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion criteria:

Patient Study Participant (PSP) Inclusion criteria:

  • Adults and adolescents with HIV-1 infection aged 12 years or older with a weight >35 kg.
  • Documented HIV-1 RNA measurements <50 copies/mL in the 12 months prior to Screening.
  • HIV-1 RNA <50 copies/mL at screening assessment.
  • Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening.
  • Any prior switch in therapy must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies/mL).

Exclusion criteria:

Patient Study Participant (PSP) Exclusion criteria:

  • Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation.
  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.
  • Any history of receiving long-acting therapy for HIV.
  • Previous exposure to CAB and/or RPV for treatment or prevention of HIV-1 infection.
  • Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation.

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: CAB ULA+ RPV ULA
Participants will receive CAB ULA+RPV ULA.
Legemiddel: CAB ULA
CAB ULA will be administered.
Legemiddel: RPV ULA
RPV ULA will be administered.
Aktiv komparator: CAB LA+ RPV LA
Participants will receive CAB LA+RPV LA.
Legemiddel: CAB LA
CAB LA will be administered.
Legemiddel: RPV LA
RPV LA will be administered.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of participants with plasma HIV-RNA greater than or equal to (>=) 50 copies (c)/mL as per Food and Drug Administration (FDA) Snapshot algorithm
Tidsramme: At Month 11
At Month 11

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm
Tidsramme: At Month 23
At Month 23
Percentage of participants with plasma HIV-RNA less than (<) 50 c/mL as per FDA Snapshot algorithm
Tidsramme: At Month 11 and Month 23
At Month 11 and Month 23
Percentage of participants with confirmed virologic failure (CVF)
Tidsramme: Up to Month 23
CVF is defined as 2 consecutive HIV-1 RNA levels >=200 c/mL.
Up to Month 23
Number of participants with drug-related adverse events (AEs) as per severity of Grade 2-5
Tidsramme: Up to Month 23
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. Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Up to Month 23
Number of participants with drug-related serious adverse events (SAEs)
Tidsramme: Up to Month 23
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.
Up to Month 23
Number of participants who discontinue treatment due to AEs or injection intolerability
Tidsramme: Up to Month 23
Up to Month 23
Number of participants with treatment emergent genotypic or phenotypic resistance to CAB and RPV
Tidsramme: Up to Month 23
Up to Month 23
Ctrough of CAB and RPV
Tidsramme: Up to Month 23
Up to Month 23
Maximum concentrations post dose (Cmax) of CAB and RPV
Tidsramme: Up to Month 23
Up to Month 23
Area under the curve (AUC) of CAB and RPV
Tidsramme: Up to Month 23
Up to Month 23
Absolute value of CD4+ cell counts in participants
Tidsramme: Up to Month 23
Up to Month 23
Change from Baseline in CD4+ cell counts in participants
Tidsramme: At Month 23 compared to baseline (Day 1)
At Month 23 compared to baseline (Day 1)

Samarbeidspartnere og etterforskere

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

Sponsor

ViiV Healthcare

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)

25. juni 2026

Primær fullføring (Antatt)

4. september 2029

Studiet fullført (Antatt)

4. september 2029

Datoer for studieregistrering

Først innsendt

10. juni 2026

Først innsendt som oppfylte QC-kriteriene

10. juni 2026

Først lagt ut (Faktiske)

16. juni 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

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 222794
  • 2024-518511-19-00 (Annen identifikator: EU CT Number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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 tohttps://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 asset(s) with development terminated across all indications.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere