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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,068 participants.

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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.

Interventions

  • DRUG nevirapine IR
  • DRUG nevirapine XR

Trial Details

FieldValue
Enrollment Target 1,068 participants
Start Date 2007-11
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT00561925

The ClinicalTrials.gov registry entry for NCT00561925 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,068 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which nevirapine IR is the first listed.

NCT00561925 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.