CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Doravirine/lamivudine/tenofovir disoproxil fumaratedrug
Likely dose
Doravirine/lamivudine/tenofovir disoproxil fumarate 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/NCT02629822
NCT02629822Phase 2Completed

A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects With Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations

Merck Sharp & Dohme LLC·interventional·Posted Dec 14, 2015·Updated Oct 26, 2021

In Brief

A Phase 2 clinical trial evaluating Doravirine/lamivudine/tenofovir disoproxil fumarate for HIV-1 Infection. Completed, enrolled 10 participants.

Detailed Summary

The primary objectives of this study are to evaluate the antiretroviral activity and the safety/tolerability of open-label doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF; MK-1439A; DELSTRIGO™) consisting of a single fixed-dose combination (FDC) tablet of DOR/3TC/TDF 100 mg/300 mg/300 mg in treatment-naïve HIV-1 infected participants with select non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance-associated mutations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 14, 2015
Enrollment StartJan 14, 2016
Primary CompletionNov 28, 2018
Study CompletionOct 28, 2020
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.5 years ago

Interventions

Doravirine/lamivudine/tenofovir disoproxil fumaratedrug

FDC tablet containing MK-1439 (doravirine) 100 mg / lamivudine 300 mg / tenofovir disoproxil fumarate 300 mg taken by mouth.