A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05766501Tipo: INTERVENTIONALInicio: 17 de mar de 2023Fin estimado: 6 de sept de 2028

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp \& Dohme (MSD)-sponsored clinical studies (MK-8591A-018, -020, and -033 \[except for heavily treatment-experienced (HTE) participants\]).

Criterios de exclusión

Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.
Is a HTE participant receiving treatment in MK-8591A-019 or -033.

Intervenciones

drug

DOR/ISL

FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily

Ubicaciones

Instituto Oulton ( Site 1004)

Córdoba, Córdoba Province, Argentina

Instituto CAICI SRL ( Site 1003)

Rosario, Santa Fe Province, Argentina

Helios Salud ( Site 1002)

Buenos Aires, Argentina

Fundación Huésped ( Site 1001)

Buenos Aires, Argentina

Fundación IDEAA ( Site 1005)

Buenos Aires, Argentina

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

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