A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05705349Tipo: INTERVENTIONALInicio: 8 de mar de 2023Fin estimado: 5 de ago de 2029

Traducción no disponible, mostrando original

Resumen

This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening
Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration

Criterios de exclusión

Has HIV-2 infection
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening
Has active hepatitis B infection (defined as hepatitis B surface antigen \[HBsAg\]-positive or HBV deoxyribonucleic acid \[DNA\]-positive).
Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid \[RNA\]) and lab values are consistent with cirrhosis
Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate

Intervenciones

drug

DOR/ISL

Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.

drug

BIC/FTC/TAF

Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.

drug

Placebo to DOR/ISL

Placebo tablet matched to DOR/ISL tablet taken by mouth.

drug

Placebo to BIC/FTC/TAF

Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.

Ubicaciones

Fundación Huésped ( Site 5850)

CABA, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 5854)

Mar del Plata, Buenos Aires, Argentina

Instituto CAICI SRL ( Site 5852)

Rosario, Santa Fe Province, Argentina

Fundación IDEAA ( Site 5851)

Buenos Aires, Argentina

Instituto Oulton ( Site 5853)

Córdoba, Argentina

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

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