Trial · NCT00561925
VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients
NCT00561925, Phase 3, Completed, Boehringer Ingelheim; results first posted 2012-01-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients. Trials, record NCT00561925. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00561925
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients
- NCT number
- NCT00561925
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,068 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- HIV Infections
- Interventions
- nevirapine IR, nevirapine XR
- First posted
- 2007-11-21
- Last updated
- 2014-04-07
- Other registries' IDs
- eudract:2007-003654-29
- Results first posted
- 2012-01-19
- Limitations and caveats
- For the lead-in-period with NVP IR 200mg QD, MedDRA Version 12.1 was used for AE/SAE reporting.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 48 | Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL |
| Secondary | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 0 to 144 | |
| Secondary | Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 144 | Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL |
| Secondary | Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population | week 0 to 144 | |
| Secondary | Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population | baseline, week 144 | |
| Secondary | Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population | baseline, week 144 | |
| Secondary | Occurrence of Rashes | until last patient completed 144 weeks (up to 193 weeks) | Frequency of patients with drug related rash events by functional grouping |
| Secondary | Occurrence of Elevations in Laboratory Measurement by DAIDS Grade | until last patient completed 144 weeks (up to 193 weeks) | |
| Secondary | Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication | week 0 to 144 | |
| Secondary | Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities | week 0 to 72 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 48 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication | participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 0 to 144 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication | proportion of participants | NUMBER |
| SECONDARY | Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 144 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication | participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population | week 0 to 144 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication | proportion of participants | NUMBER |
| SECONDARY | Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population | baseline, week 144 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases | log10 copies/mL | MEAN |
| SECONDARY | Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population | baseline, week 144 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases | cells/cubic millimeter | MEAN |
| SECONDARY | Occurrence of Rashes | until last patient completed 144 weeks (up to 193 weeks) | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication | participants | NUMBER |
| SECONDARY | Occurrence of Elevations in Laboratory Measurement by DAIDS Grade | until last patient completed 144 weeks (up to 193 weeks) | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication | participants | NUMBER |
| SECONDARY | Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication | week 0 to 144 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication | cumulative probability | NUMBER |
| SECONDARY | Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities | week 0 to 72 | Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose | cumulative probability | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group262
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | NVP IR 200mg BID | Responder | 384 | participants | |
| Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | NVP XR 400mg QD | Responder | 409 | participants | |
| Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | NVP IR 200mg BID | Non responder | 122 | participants | |
| Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | NVP XR 400mg QD | Non responder | 96 | participants | |
| Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | NVP IR 200mg BID | Interval Week 0 to <2 | 1 | proportion of participants | |
| Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | NVP XR 400mg QD | Interval Week 0 to <2 | 1 | proportion of participants | |
| Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | NVP IR 200mg BID | Interval Week 2 to <4 | 0.84 | proportion of participants | |
| Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | NVP XR 400mg QD | Interval Week 2 to <4 | 0.865 | proportion of participants | |
| Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | NVP IR 200mg BID | Interval Week 4 to <6 | 0.838 | proportion of participants | |
| Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | NVP XR 400mg QD | Interval Week 4 to <6 | 0.865 | proportion of participants |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 14 Day Lead-In Period | STARTED | NVP IR 200mg QD | 1,068 | |
| 14 Day Lead-In Period | STARTED | NVP IR 200mg BID | 0 | |
| 14 Day Lead-In Period | STARTED | NVP XR 400mg QD | 0 | |
| 14 Day Lead-In Period | STARTED | NVP XR | 0 | |
| 14 Day Lead-In Period | STARTED | NVP IR to XR | 0 | |
| 14 Day Lead-In Period | COMPLETED | NVP IR 200mg QD | 1,013 | |
| 14 Day Lead-In Period | COMPLETED | NVP IR 200mg BID | 0 | |
| 14 Day Lead-In Period | COMPLETED | NVP XR 400mg QD | 0 | |
| 14 Day Lead-In Period | COMPLETED | NVP XR | 0 | |
| 14 Day Lead-In Period | COMPLETED | NVP IR to XR | 0 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events1,320
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | NVP IR 200mg QD | 8 | 1,068 | |
| other | Abdominal pain | Gastrointestinal disorders | NVP IR | 7 | 191 | |
| other | Abdominal pain | Gastrointestinal disorders | NVP XR | 25 | 505 | |
| other | Abdominal pain | Gastrointestinal disorders | NVP IR-IR/XR | 25 | 315 | |
| other | Abdominal pain | Gastrointestinal disorders | NVP XR-IR/XR | 2 | 315 | |
| other | Diarrhoea | Gastrointestinal disorders | NVP IR 200mg QD | 27 | 1,068 | |
| other | Diarrhoea | Gastrointestinal disorders | NVP IR | 27 | 191 | |
| other | Diarrhoea | Gastrointestinal disorders | NVP XR | 94 | 505 | |
| other | Diarrhoea | Gastrointestinal disorders | NVP IR-IR/XR | 63 | 315 | |
| other | Diarrhoea | Gastrointestinal disorders | NVP XR-IR/XR | 7 | 315 |
1 to 10 of 1,320Source ClinicalTrials.gov
See all 1,320 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NVP IR 200mg QD | ||
| Total, all-cause mortality | NVP IR | ||
| Total, all-cause mortality | NVP XR | ||
| Total, all-cause mortality | NVP IR-IR/XR | ||
| Total, all-cause mortality | NVP XR-IR/XR | ||
| Total, other adverse events | NVP IR 200mg QD | 308 | 1,068 |
| Total, other adverse events | NVP IR | 131 | 191 |
| Total, other adverse events | NVP XR | 403 | 505 |
| Total, other adverse events | NVP IR-IR/XR | 271 | 315 |
| Total, other adverse events | NVP XR-IR/XR | 81 | 315 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21817198 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00561925
GET https://conductscience.org/api/trials/v1/NCT00561925/results?page=2