A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY) (CINERGY)
6. september 2026 oppdatert av: ViiV Healthcare
A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of 2-drug Injectable Regimens of VH4011499 Plus Cabotegravir in Treatment Naïve Viremic Adult Participants With HIV-1 (CINERGY)
The purpose of this Phase 2b study is to evaluate the efficacy and therapeutic window of chronically dosed VH4011499 paired with an integrase strand transfer inhibitor (INSTI).
This study will explore 4 different regimens of VH4011499 when paired with cabotegravir (CAB) as an initial two-drug regimen.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
200
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: US GSK Clinical Trials Call Center
- Telefonnummer: 877-379-3718
- E-post: GSKClinicalSupportHD@gsk.com
Studer Kontakt Backup
- Navn: EU GSK Clinical Trials Call Center
- Telefonnummer: +44 (0) 20 89904466
- E-post: GSKClinicalSupportHD@gsk.com
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
Inclusion Criteria:
- Participant must be at least 18 years of age (or older, if required for adults by local regulations).
- Screening CD4+ T-cell count ≥ 200 cells/µL.
Documented HIV-1 infection and screening plasma HIV-1 RNA ≥
1 000 and ≤ 100 000 copies/mL.
- Treatment-naïve. Prior use of oral pre-exposure prophylaxis (PrEP) or oral post-exposure prophylaxis (PEP) that is not INSTI or CAI based is permitted.
- Body weight ≥ 50.0 kg (110 lbs) for participants assigned male at birth and ≥ 45.0 kg (99 lbs) for participants assigned female at birth.
- Agrees to adequate birth control if a participant of childbearing potential
Exclusion Criteria:
- Participants with acute HIV-1 infection
- Prior exposure to any HIV-1 capsid inhibitor or any HIV-1 INSTI for any reason is prohibited.
- Participants with known or suspected presence of major virologic resistance mutations to study drugs
- Unstable liver disease
- Participants with HCV co-infection
- Participant has evidence of chronic active HBV infection
- Clinically significant cardiovascular disease
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: VH4011499 dose Group 1 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 1, which differs from all other arms) and cabotegravir (CAB).
|
Participants receive injectable VH4011499 at different dose groups.
Participants receive injectable CAB.
|
|
Eksperimentell: VH4011499 dose Group 2 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 2, which differs from all other arms) and CAB.
|
Participants receive injectable VH4011499 at different dose groups.
Participants receive injectable CAB.
|
|
Eksperimentell: VH4011499 dose Group 3 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 3, which differs from all other arms) and CAB.
|
Participants receive injectable VH4011499 at different dose groups.
Participants receive injectable CAB.
|
|
Eksperimentell: VH4011499 dose Group 4 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 4, which differs from all other arms) and CAB.
|
Participants receive injectable VH4011499 at different dose groups.
Participants receive injectable CAB.
|
|
Aktiv komparator: DTG/3TC
Active control arm receiving daily oral standard of care antiretroviral therapy (dolutegravir 50 mg / lamivudine 300 mg single-tablet regimen).
|
Participants receive DTG/3TC orally once daily.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm
Tidsramme: At Month 7
|
At Month 7
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm
Tidsramme: At Month 13 and Month 25
|
At Month 13 and Month 25
|
|
|
Number of participants with plasma HIV-1 RNA <50 copies/mL as per observed data
Tidsramme: At Month 7, Month 13 and Month 25
|
At Month 7, Month 13 and Month 25
|
|
|
Change from baseline (Day 1) in cluster of differentiation (CD) 4+ T-cell count
Tidsramme: At Month 7, Month 13 and Month 25
|
At Month 7, Month 13 and Month 25
|
|
|
Number of participants with injection site reaction adverse events of special interest (ISR AESIs) by grade
Tidsramme: Through Month 7, Month 13 and Month 25
|
The ISR AESIs will be graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.
|
Through Month 7, Month 13 and Month 25
|
|
Duration of ISR AESIs by grade
Tidsramme: Through Month 7, Month 13 and Month 25
|
The ISR AESIs will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.
|
Through Month 7, Month 13 and Month 25
|
|
Number of participants with serious adverse events (SAEs) by grade
Tidsramme: Through Month 7, Month 13 and Month 25
|
An SAE is defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment.
The SAEs will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
|
Through Month 7, Month 13 and Month 25
|
|
Number of participants with adverse events (AEs) leading to study treatment discontinuation, by grade
Tidsramme: Through Month 7, Month 13 and Month 25
|
The AEs leading to treatment discontinuation will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
|
Through Month 7, Month 13 and Month 25
|
|
Plasma concentrations of VH4011499
Tidsramme: Through Months 7, 13 and 25
|
Through Months 7, 13 and 25
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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 (Antatt)
19. oktober 2026
Primær fullføring (Antatt)
10. juni 2032
Studiet fullført (Antatt)
11. juni 2032
Datoer for studieregistrering
Først innsendt
6. september 2026
Først innsendt som oppfylte QC-kriteriene
6. september 2026
Først lagt ut (Faktiske)
11. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Blodbårne infeksjoner
- Urogenitale sykdommer
- Kjønnssykdommer
- Sykdommer i immunsystemet
- Infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- HIV-infeksjoner
Andre studie-ID-numre
- 308532
- 2026-526236-39 (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_28May2026.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. .