Phase 2 Study of Doravirine Alone or Combined with Lamivudine and Tenofovir in Children With HIV-1 Aged 4 Weeks to Under 12 Years and Weighing Less Than 45 kg

What this Trial Is About

Researchers are evaluating the pharmacokinetics, safety, and efficacy of doravirine DOR and a fixed-dose combination of doravirinelamivudinetenofovir disoproxil fumarate DOR3TCTDF in children aged 4 weeks to under 12 years who weigh less than 45 kg and are infected with human immunodeficiency virus type 1 HIV-1. The study includes participants who are either treatment-naive or have been virologically suppressed on stable combination antiretroviral therapy for at least 3 months without treatment failure. The goal is to understand how DOR behaves in the body and its safety when used with other antiretrovirals in this pediatric population. Participants receive DOR doses ranging from 7.2 mg to 100 mg based on weight, combined with two nucleosidenucleotide analog reverse transcriptase inhibitors NRTIs as per local guidelines, or a fixed-dose combination of DOR3TCTDF tailored to weight. Treatment lasts for 96 weeks, and those completing the Week 96 visit may join an extension study to continue receiving DOR for up to 224 additional weeks or until it becomes commercially available. Throughout the study, participants undergo intensive pharmacokinetic sampling to measure drug concentrations at specific time points, safety monitoring for adverse events, and evaluations of HIV-1 viral load and immune cell counts at various weeks up to Week 96. Researchers also assess adherence to the medication regimens and the palatability of the oral pellets or granules. The total duration of participation can extend up to several years, including the extension phase.

Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)