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NCT00561925 · ClinicalTrials.gov registry record · Phase 3
VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,068
- Enrollment target
NCT00561925: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00561925 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,068 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00561925, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,068 participants
- Enrollment target
Study 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.
Primary Outcome
Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL
Interventions
- DRUG nevirapine IR
- DRUG nevirapine XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,068 participants |
| Start Date | 2007-11 |
| Phase | Phase 3 |
What the finished NCT00561925 record still lists
NCT00561925 is an interventional study that assigns participants to a tested intervention. Its 1,068 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 2 interventions - of which nevirapine IR is the first listed.
NCT00561925 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00561925 about?
NCT00561925 is a clinical study titled "VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients". 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 ...
What is the current status of trial NCT00561925?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,068 participants. The study started on 2007-11.
What interventions are being tested in trial NCT00561925?
The interventions under investigation include: nevirapine IR (DRUG), nevirapine XR (DRUG).
Who is sponsoring clinical trial NCT00561925?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00561925's enrollment target sits among peer trials
1,068 272nd of 2000 higher than 1,727 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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