CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 636 enrolled
Drug / intervention
Efavirenz 600mg +1 moredrug
Likely dose
Efavirenz 600mgfrom 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/NCT01011413
NCT01011413Phase 3Completed
CompareCT.gov

A Randomised, Double-blind, Placebo-controlled, Trial to Compare the Safety and Efficacy of Reduced Dose Versus Standard Dose EFV Plus Two Nucleotides (N(t)RTI) in Antiretroviral-naïve HIV-infected Adults Over 96 Weeks

Kirby Institute·interventional·Posted Nov 11, 2009·Updated Feb 21, 2020

In Brief

A Phase 3 clinical trial evaluating Efavirenz 600mg and Efavirenz 400mg for HIV Infections. Completed, enrolled 636 participants across 1 site.

Detailed Summary

Clinical data suggests that the standard dose of the anti-HIV medication, efavirenz (EFV), could be reduced without compromising its effectiveness. Lower drug doses could have fewer side effects and would make EFV more affordable. The purpose of this study is to compare the safety and effectiveness, over 96 weeks, of standard (600mg) versus reduced dose (400mg) EFV in controlling HIV as part of initial combination antiretroviral therapy.

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2009
Enrollment StartAug 1, 2011
Primary CompletionJun 1, 2013
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.6 years ago

Interventions

Efavirenz 600mgdrug

3 x EFV 200 milligram (mg) tablets once daily

Efavirenz 400mgdrug

2 x EFV 200 milligram (mg) tablets plus 1x matched EFV placebo tablet once daily