Trial · NCT00819052
Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients
NCT00819052, Phase 3, Completed, Boehringer Ingelheim; results first posted 2012-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients. Trials, record NCT00819052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00819052
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients
- NCT number
- NCT00819052
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 445 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- HIV Infections
- Interventions
- Nevirapine XR, Nevirapine XR, Nevirapine IR
- First posted
- 2009-01-08
- Last updated
- 2014-11-10
- Other registries' IDs
- eudract:2008-004681-55
- Results first posted
- 2012-02-24
Source ClinicalTrials.gov
Registered outcomes43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 24 | Primary endpoint was the number of patients with a sustained virologic response through week 24 |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | week 2 | Endpoint was the number of patients with a sustained virologic response through week 2 |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | week 4 | Endpoint was the number of patients with a sustained virologic response through week 4 |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | week 8 | Endpoint was the number of patients with a sustained virologic response through week 8 |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | week 12 | Endpoint was the number of patients with a sustained virologic response through week 12 |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | week 24 | Endpoint was the number of patients with a sustained virologic response through week 24 |
| 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 24 | |
| Secondary | Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population | week 0 | |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population | baseline, week 2 | |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population | baseline, week 4 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 registered outcomesOutcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 24 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | participants | NUMBER |
| SECONDARY | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | week 2 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | participants | NUMBER |
| SECONDARY | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | week 4 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | participants | NUMBER |
| SECONDARY | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | week 8 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | participants | NUMBER |
| SECONDARY | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | week 12 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | participants | NUMBER |
| SECONDARY | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | week 24 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | 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 24 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | proportion of participants | NUMBER |
| SECONDARY | Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population | week 0 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline. | cells/cubic millimeter | MEAN |
| SECONDARY | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population | baseline, week 2 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 2. | cells/cubic millimeter | MEAN |
| SECONDARY | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population | baseline, week 4 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 4. | cells/cubic millimeter | MEAN |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 outcomesResults by group234
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Nevirapine Immediate Release (NVP IR) | Responder | 137 | participants | |
| Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Nevirapine Extended Release (NVP XR) | Responder | 276 | participants | |
| Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Nevirapine Immediate Release (NVP IR) | Non responder | 11 | participants | |
| Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Nevirapine Extended Release (NVP XR) | Non responder | 19 | participants | |
| Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Nevirapine Immediate Release (NVP IR) | Responder | 148 | participants | |
| Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Nevirapine Extended Release (NVP XR) | Responder | 292 | participants | |
| Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Nevirapine Immediate Release (NVP IR) | Non responder | 0 | participants | |
| Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Nevirapine Extended Release (NVP XR) | Non responder | 3 | participants | |
| Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Nevirapine Immediate Release (NVP IR) | Responder | 146 | participants | |
| Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Nevirapine Extended Release (NVP XR) | Responder | 291 | participants |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nevirapine Immediate Release (NVP IR) | 148 | |
| Overall Study | STARTED | Nevirapine Extended Release (NVP XR) | 295 | |
| Overall Study | COMPLETED | Nevirapine Immediate Release (NVP IR) | 142 | |
| Overall Study | COMPLETED | Nevirapine Extended Release (NVP XR) | 281 | |
| Overall Study | NOT COMPLETED | Nevirapine Immediate Release (NVP IR) | 6 | |
| Overall Study | NOT COMPLETED | Nevirapine Extended Release (NVP XR) | 14 |
Source ClinicalTrials.gov
Adverse events302
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 | Conjunctivitis | Eye disorders | Nevirapine Immediate Release (NVP IR) | 8 | 148 | |
| other | Conjunctivitis | Eye disorders | Nevirapine Extended Release (NVP XR) | 11 | 295 | |
| other | Diarrhoea | Gastrointestinal disorders | Nevirapine Immediate Release (NVP IR) | 20 | 148 | |
| other | Diarrhoea | Gastrointestinal disorders | Nevirapine Extended Release (NVP XR) | 62 | 295 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Nevirapine Immediate Release (NVP IR) | 2 | 148 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Nevirapine Extended Release (NVP XR) | 16 | 295 | |
| other | Nausea | Gastrointestinal disorders | Nevirapine Immediate Release (NVP IR) | 4 | 148 | |
| other | Nausea | Gastrointestinal disorders | Nevirapine Extended Release (NVP XR) | 20 | 295 | |
| other | Fatigue | General disorders | Nevirapine Immediate Release (NVP IR) | 9 | 148 | |
| other | Fatigue | General disorders | Nevirapine Extended Release (NVP XR) | 30 | 295 |
1 to 10 of 302Source ClinicalTrials.gov
See all 302 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nevirapine Immediate Release (NVP IR) | ||
| Total, all-cause mortality | Nevirapine Extended Release (NVP XR) | ||
| Total, other adverse events | Nevirapine Immediate Release (NVP IR) | 110 | 148 |
| Total, other adverse events | Nevirapine Extended Release (NVP XR) | 244 | 295 |
| Total, serious adverse events | Nevirapine Immediate Release (NVP IR) | 33 | 148 |
| Total, serious adverse events | Nevirapine Extended Release (NVP XR) | 73 | 295 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nevirapine Immediate Release (NVP IR) vs Nevirapine Extended Release (NVP XR): Occurence of Hepatic Events | Trial comparisons |
| Nevirapine Immediate Release (NVP IR) vs Nevirapine Extended Release (NVP XR): serious adverse events | Trial comparisons |
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/NCT00819052
GET https://conductscience.org/api/trials/v1/NCT00819052/registered?page=2