At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,068 enrolled
Drug / intervention
nevirapine IR +1 moredrug
Likely dose
nevirapine IR 200 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.
A Randomised, Double Blind, Double Dummy, Parallel Group, Active Controlled Trial to Evaluate the Antiviral Efficacy of 400 mg QD neVirapine Extended Release Formulation in Comparison to 200 mg BID neVirapinE Immediate Release in Combination With Truvada® in Antiretroviral Therapy naïve HIV-1 Infected Patients (VERxVE)
In Brief
A Phase 3 clinical trial evaluating nevirapine IR and nevirapine XR for HIV Infections. Completed, enrolled 1,068 participants across 202 sites in 21 countries.
Detailed Summary
The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesArgentina, Australia, Belgium, Botswana, Canada, France, Germany, Ireland, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, South Africa, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
First PostedNov 2007
Primary CompletionNov 2011
TodayJul 2026
First PostedNov 21, 2007
Enrollment StartNov 1, 2007
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 18.6 years ago
Interventions
nevirapine IRdrug
200 mg BID
nevirapine XRdrug
400 mg QD