CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 566 enrolled
Drug / intervention
MK-0518 +4 moredrug
Likely dose
MK-0518 400 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/NCT00369941
NCT00369941Phase 3Completed
CompareCT.gov

A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™

Merck Sharp & Dohme LLC·interventional·Posted Aug 30, 2006·Updated Mar 21, 2017

In Brief

A Phase 3 clinical trial evaluating MK-0518, Comparator: efavirenz, and 3 other interventions for HIV Infections. Completed, enrolled 566 participants.

Detailed Summary

This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 30, 2006
Enrollment StartAug 1, 2006
Primary CompletionMay 1, 2009
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.8 years ago

Interventions

MK-0518drug

400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks

Comparator: efavirenzdrug

600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks

Comparator: Truvadadrug

One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir)

Comparator: Placebo to MK-0518drug

Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks

Comparator: Placebo to efavirenzdrug

Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks