CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Doravirine (DOR) +2 moredrug
Likely dose
Doravirine (DOR) 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03332095
NCT03332095Phase 2Completed
CompareCT.gov

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Nov 6, 2017·Updated Feb 14, 2023

In Brief

A Phase 2 clinical trial evaluating Doravirine (DOR), Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF), and 1 other intervention for HIV Infections. Completed, enrolled 55 participants across 8 sites in 3 countries.

Detailed Summary

The purpose of this study was 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesSouth Africa, Thailand, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 6, 2017
Enrollment StartJul 2, 2018
Primary CompletionAug 19, 2020
Study CompletionMay 25, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.7 years ago

Interventions

Doravirine (DOR)drug

100 mg of DOR administered orally

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF)drug

DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Antiretroviral (ARV) medicationsdrug

Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not provided by the study.