At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 445 enrolled
Drug / intervention
Nevirapine XR +2 moredrug
Likely dose
Not stated in 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.
An Open Label, Phase IIIb, Randomised Parallel Group Study to Assess the Efficacy and Safety of Switching HIV-1 Infected Patients Successfully Treated With a Nevirapine IR Based Regiment to Nevirapine XR 400 mg QD or Remaining on Nevirapine IR 200 mg BID Based Program
In Brief
A Phase 3 clinical trial evaluating Nevirapine XR and Nevirapine IR for HIV Infections. Completed, enrolled 445 participants across 39 sites in 4 countries.
Detailed Summary
The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesFrance, Germany, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2008
First PostedJan 2009
Primary CompletionJan 2012
TodayJul 2026
First PostedJan 8, 2009
Enrollment StartDec 1, 2008
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.5 years ago
Interventions
Nevirapine XRdrug
Nevirapine XR
Nevirapine XRdrug
Nevirapine extended release
Nevirapine IRdrug
Nevirapine Immediate Release