Resumen

This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL \[also known as MK-8591A\]) in treatment-naïve participants living with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.

Descripción detallada

Double-blind treatment with the assigned intervention occurs from Day 1 to Week 96, followed by an open-label portion up to Week 144. Participants who benefit from treatment in the opinion of the Investigator may continue their assigned intervention up to Week 168 (or until they have the option to enroll in a DOR/ISL 100 mg/0.25 mg study, whichever is sooner).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Is human immunodeficiency virus type 1 (HIV-1) positive
Is naïve to antiretroviral therapy (ART) defined as having received ≤10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection including prevention of mother-to-child transmission up to 1 month prior to screening.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); 2) Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis); 3) A WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before the first dose of study intervention; 4) If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required

Criterios de exclusión

Has human immunodeficiency virus type 2 (HIV-2) infection
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
Has an active diagnosis of hepatitis due to any cause, including active hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen \[HBsAg\]-positive or hepatitis B virus deoxyribonucleic acid \[HBV DNA\]-positive)
Has a history of malignancy ≤5 years prior to signing 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
Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1
Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapy from 45 days prior to Day 1 through the study intervention period
Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study intervention period
Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, or any study intervention
Has exclusionary laboratory values within 45 days prior to Day 1
Is female and is expecting to conceive or donate eggs at any time during the study

Intervenciones

drug

DOR/ISL

100 mg DOR/0.75 mg ISL FDC single tablet taken once daily by mouth.

drug

BIC/FTC/TAF

BIC/FTC/TAF 50/200/25 mg FDC single tablet taken once daily by mouth.

drug

Placebo to BIC/FTC/TAF

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

drug

Placebo to DOR/ISL

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

Ubicaciones

Helios Salud S.A. ( Site 5802)

Buenos Aires, Buenos Aires F.D., Argentina

IDEAA Foundation ( Site 5807)

Buenos Aires, Buenos Aires F.D., Argentina

Fundación Huesped ( Site 5801)

C.a.b.a, Buenos Aires F.D., Argentina

Instituto CAICI ( Site 5803)

Rosario, Santa Fe Province, Argentina

Instituto Oulton ( Site 5804)

Córdoba, Argentina

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

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

DOR/ISL

BIC/FTC/TAF

Placebo to BIC/FTC/TAF

Placebo to DOR/ISL

Ubicaciones

Helios Salud S.A. ( Site 5802)

IDEAA Foundation ( Site 5807)

Fundación Huesped ( Site 5801)

Instituto CAICI ( Site 5803)

Instituto Oulton ( Site 5804)

Patrocinadores