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Phase I/II Study of the Pharmacokinetics, Safety and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-infected Children and Adolescents
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IMPAACT 2014 is a Phase I/II, multi-center, open-label, non-comparative pharmacokinetic (PK) and safety study of doravirine (DOR, MK-1439) and a fixed dose combination of doravirine, lamivudine and tenofovir disoproxil fumarate (DOR/3TC/TDF, MK-1439a) in adolescents living with HIV (less than 18 years of age and weighing at least 35 kgs). Two sequential dosing cohorts will be enrolled:
- Up to 20 virologically suppressed adolescents will be enrolled in Cohort 1. Participants receiving an ARV regimen of dolutegravir (DTG) or raltegravir (RAL) plus 2 NRTIs will be given a single dose of DOR, added to the ARV regimen, and intensive PK sampling will be conducted around DOR. These participants will be followed for two weeks for safety.
- Up to 45 ARV treatment naïve or virologically suppressed adolescents will be enrolled in Cohort 2. DOR/3TC/TDF will be initiated at entry and these participants will be followed for 96 weeks for safety, virologic and immunologic outcomes.
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