Trial Profile

A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in Participants With HIV-1, Who Are 4 Weeks to Less Than 12 Years of Age and Weigh Less Than 45 kg

Status: Recruiting

Phase of Trial: Phase II

Latest Information Update: 16 Jul 2025

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At a glance

Drugs Doravirine (Primary) ; Doravirine/lamivudine/tenofovir disoproxil fumarate (Primary)
Indications HIV-1 infections
Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
Acronyms MK-1439-066
Sponsors Merck Sharp & Dohme Corp.

13 Aug 2023 Planned End Date changed from 3 Nov 2026 to 11 Apr 2034.
13 Aug 2023 Planned primary completion date changed from 3 Jun 2025 to 4 Mar 2028.
21 Jan 2021 Planned initiation date (estimated date for recruitment of the first subject) changed from 21 Dec 2020 to 03 Feb 2021.

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