CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 694 enrolled
Drug / intervention
TMC278 +1 moredrug
Likely dose
TMC278 25 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/NCT00540449
NCT00540449Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Double-blind Trial of TMC278 25 mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Fixed Background Regimen Consisting of Tenofovir Disoproxil Fumarate and Emtricitabine in Antiretroviral-naive HIV-1 Infected Subjects.

Tibotec Pharmaceuticals, Ireland·interventional·Posted Oct 8, 2007·Updated Mar 29, 2016

In Brief

A Phase 3 clinical trial evaluating TMC278 and Efavirenz for HIV Infections and 2 related conditions. Completed, enrolled 694 participants across 92 sites in 20 countries.

Detailed Summary

The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, HIV-1, Human Immunodeficiency Virus Type 1
CountriesArgentina, Australia, Austria, Brazil, Canada, Denmark, France, Mexico, Netherlands, Portugal, Puerto Rico, Romania, Russia, South Africa, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 8, 2007
Enrollment StartMay 1, 2008
Primary CompletionFeb 1, 2010
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.7 years ago

Interventions

TMC278drug

25 mg tablet once daily for 96 weeks

Efavirenzdrug

600mg once daily for 96 weeks