Last updated on December 2019

Evaluating the Pharmacokinetics Safety and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents

Brief description of study

The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of doravirine (also called MK-1439 or DOR) and doravirine/lamivudine/tenofovir disoproxil fumarate (also called MK-1439A or DOR/3TC/TDF) in HIV-1-infected children and adolescents.

Detailed Study Description

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of DOR and DOR/3TC/TDF in HIV-1-infected children and adolescents.

This study will be conducted in two cohorts: Cohort 1 and Cohort 2. At study entry (Day 0), participants in Cohort 1 will receive a single dose of DOR added to their current HIV regimens. (The antiretroviral drugs in their current HIV regimens will not be provided by the study.) Participants in Cohort 1 will undergo intensive PK evaluations, and they will have an additional study visit at Week 2.

The study team in consultation with a Study Monitoring Committee will evaluate data from Cohort 1 before enrolling participants in Cohort 2. Participants in Cohort 2 will receive DOR/3TC/TDF once daily from Day 0 through Week 96. They will attend study visits at Weeks 1, 2, 4, 8, 12, 16, 24, 36, 48, 64, 80, and 96. Study visits will include physical examinations, PK evaluations, and blood and urine collection.

Clinical Study Identifier: NCT03332095

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