At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
Rilpivirinedrug
Likely dose
Rilpivirine 26mgfrom 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 Phase I Pharmacokinetic Study to Assess the Cerebrospinal-fluid (CSF) Exposure of Rilpivirine in HIV-infected Subjects Switching From TDF/FTC/Nevirapine to TDF/FTC/Rilpivirine
In Brief
A Phase 1 clinical trial evaluating Rilpivirine for HIV. Completed, enrolled 14 participants across 1 site.
Detailed Summary
This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. The participants will then restart their original regime with nevirapine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited Kingdom
CollaboratorsJanssen-Cilag Ltd.
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2012
First PostedMar 2012
Primary CompletionNov 2012
Study CompletionFeb 2013
TodayJul 2026
First PostedMar 26, 2012
Enrollment StartMar 1, 2012
Primary CompletionNov 1, 2012
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.3 years ago
Interventions
Rilpivirinedrug
Rilpivirine 26mg