Conditions: HIV-1 Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 18
Healthy volunteers: no

Brief summary:
This is a study to evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of doravirine (MK-1439) as monotherapy in antiretroviral therapy (ART)-naïve, HIV-1-infected participants.

Detailed description:

Arms:
arm 1: Participants will receive oral doses of doravirine 25 mg or placebo once daily for 7 days. arm 2: Panel B (doravirine 200 mg or placebo once daily for 7 days) will initiate upon satisfactory review of safety and tolerability from Panel A, and all safety, tolerability and pharmacokinetic data from the study MK-1439-001. arm 3: Panel C is optional. If conducted, the dose will be confirmed after review of data from prior panels.

Interventions: intervention 1: Doravirine intervention 2: Placebo
Intervention descriptions: intervention 1: Doravirine tablets, orally, once daily for 7 days at a dose of 25 mg in Panel A and 200 mg in Panel B; dose in Panel C to be determined (≤200 mg). intervention 2: Placebo tablets once daily for 7 days.

Protocol document: