Trial · NCT00089505
NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission
NCT00089505, Phase 3, Completed, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections; results first posted 2011-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission. Trials, record NCT00089505. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00089505
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission
- NCT number
- NCT00089505
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 745 participants, actual
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Conditions
- HIV Infections
- Interventions
- Emtricitabine, Emtricitabine/Tenofovir disoproxil fumarate, Lopinavir/Ritonavir, Nevirapine, Tenofovir disoproxil fumarate
- First posted
- 2004-08-06
- Last updated
- 2018-10-12
- Results first posted
- 2011-02-04
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry | Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks. | 5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is \>=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. |
| Primary | Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry | Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks. | 5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is \>=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. |
| Secondary | Number of Participants Who Experienced Virologic Failure or Died. | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. | Virologic failure (VF) is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is \>=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. |
| Secondary | Percent of Participants Who Experienced Virologic Failure or Died | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms. | Results report cumulative percent of participants reaching virologic failure (VF) or death by week 48 and week 96 calculated using the Kaplan-Meier method. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is \>=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. |
| Secondary | CD4 Count Change From Randomization | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96. | Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (last CD4 before/on treatment start date). For NVP/NVP and NVP/LPV\_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV\_r arms, since the follow-up continued as planned, data through overall study were used. |
| Secondary | Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen. | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. | The outcome is defined as treatment-related toxicity (as evaluated by sites), regardless of grade, that led to discontinuation of randomized regimen. For NVP/NVP and NVP/LPV\_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV\_r arms, since the follow-up continued as planned, data through overall study were used. |
| Secondary | Number of Participants Who Experienced HIV-related Disease Progression or Death | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. | Worsening to WHO stage III/IV (among subjects who had WHO stage I/II at baseline) and death were the composite secondary endpoint. WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents is an approach for use in resource limited settings in studies of progression to symptomatic HIV disease. There are 4 stages of disease staging, 1 being the least severe and 4 being the most severe disease stage based on the HIV related symptoms and diagnoses. Please refer to the following web page for detailed staging criteria: http://www.who.int/docstore/hiv/scaling/anex1.html |
| Secondary | Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm. | Any grade of rash or grade 2+ liver lab abnormality events that were claimed to be NVP associated (definitely, probably, or possibly) by site investigators were evaluated. Grade 2+ liver lab abnormality is defined as aspartate aminotransferase (AST)\>=2.6 x ULN or alanine aminotransferase (ALT)\>=2.6 x ULN. |
| Secondary | Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms. | Self-reported adherence at week 48 and 96 while participants remained on randomized regimen. Adherence interviews for each antiretroviral drug drug the participant is taking was performed by site personnel every 24 weeks. For NVP/NVP and NVP/LPV\_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV\_r arms, since the follow-up continued as planned, data through overall study were used. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Participants Who Experienced Virologic Failure or Died. | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. | Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment). | participants | NUMBER |
| SECONDARY | Percent of Participants Who Experienced Virologic Failure or Died | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms. | Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment). | Percent of participants | NUMBER |
| SECONDARY | CD4 Count Change From Randomization | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96. | Changes were calculated using the intent-to-treat approach (i.e. ignoring changes from randomized treatment) but no imputation was done for missing values. | cells/mm^3 | MEDIAN |
| SECONDARY | Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen. | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. | Numbers presented use as-treated method. | participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced HIV-related Disease Progression or Death | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. | Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment). | participants | NUMBER |
| PRIMARY | Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry | Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks. | Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment). | weeks | NUMBER |
| PRIMARY | Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry | Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks. | The analysis was intent to treat per protocol. | weeks | NUMBER |
| SECONDARY | Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm. | Numbers presented use the as-treated approach. | participants | NUMBER |
| SECONDARY | Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month | Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms. | Numbers presented use as-treated approach. | percent of participants | NUMBER |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced Virologic Failure or Died. | NVP/NVP | 32 | participants | ||
| Number of Participants Who Experienced Virologic Failure or Died. | NVP/LPV_r | 10 | participants | ||
| Number of Participants Who Experienced Virologic Failure or Died. | NoNVP/NVP | 42 | participants | ||
| Number of Participants Who Experienced Virologic Failure or Died. | NoNVP/LPV_r | 50 | participants | ||
| Percent of Participants Who Experienced Virologic Failure or Died | NVP/NVP | week 48 percent of virologic failure or death | 23 | 95% Confidence Interval 16 to 31 | Percent of participants |
| Percent of Participants Who Experienced Virologic Failure or Died | NVP/LPV_r | week 48 percent of virologic failure or death | 4 | 95% Confidence Interval 1 to 8 | Percent of participants |
| Percent of Participants Who Experienced Virologic Failure or Died | NoNVP/NVP | week 48 percent of virologic failure or death | 14 | 95% Confidence Interval 10 to 19 | Percent of participants |
| Percent of Participants Who Experienced Virologic Failure or Died | NoNVP/LPV_r | week 48 percent of virologic failure or death | 14 | 95% Confidence Interval 9 to 18 | Percent of participants |
| Percent of Participants Who Experienced Virologic Failure or Died | NVP/NVP | week 96 percent of virologic failure or death | 31 | 95% Confidence Interval 21 to 40 | Percent of participants |
| Percent of Participants Who Experienced Virologic Failure or Died | NVP/LPV_r | week 96 percent of virologic failure or death | 12 | 95% Confidence Interval 5 to 20 | Percent of participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NVP/NVP | 121 | |
| Overall Study | STARTED | NVP/LPV_r | 120 | |
| Overall Study | STARTED | NoNVP/NVP | 249 | |
| Overall Study | STARTED | NoNVP/LPV_r | 251 | |
| Overall Study | COMPLETED | NVP/NVP | 112 | |
| Overall Study | COMPLETED | NVP/LPV_r | 118 | |
| Overall Study | COMPLETED | NoNVP/NVP | 228 | |
| Overall Study | COMPLETED | NoNVP/LPV_r | 230 | |
| Overall Study | NOT COMPLETED | NVP/NVP | 9 | |
| Overall Study | NOT COMPLETED | NVP/LPV_r | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events384
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 | Lymphadenopathy | Blood and lymphatic system disorders | NVP/NVP | 4 | 121 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | NVP/LPV_r | 9 | 120 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | NoNVP/NVP | 17 | 249 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | NoNVP/LPV_r | 12 | 251 | |
| other | Abdominal pain | Gastrointestinal disorders | NVP/NVP | 14 | 121 | |
| other | Abdominal pain | Gastrointestinal disorders | NVP/LPV_r | 12 | 120 | |
| other | Abdominal pain | Gastrointestinal disorders | NoNVP/NVP | 22 | 249 | |
| other | Abdominal pain | Gastrointestinal disorders | NoNVP/LPV_r | 26 | 251 | |
| other | Abdominal pain lower | Gastrointestinal disorders | NVP/NVP | 3 | 121 | |
| other | Abdominal pain lower | Gastrointestinal disorders | NVP/LPV_r | 8 | 120 |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NVP/NVP | ||
| Total, all-cause mortality | NVP/LPV_r | ||
| Total, all-cause mortality | NoNVP/NVP | ||
| Total, all-cause mortality | NoNVP/LPV_r | ||
| Total, other adverse events | NVP/NVP | 110 | 121 |
| Total, other adverse events | NVP/LPV_r | 105 | 120 |
| Total, other adverse events | NoNVP/NVP | 225 | 249 |
| Total, other adverse events | NoNVP/LPV_r | 227 | 251 |
| Total, serious adverse events | NVP/NVP | 9 | 121 |
| Total, serious adverse events | NVP/LPV_r | 6 | 120 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers14
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI068636 | AIDS Clinical Trials Group Network | KURITZKES, DANIEL R. | SOCIAL AND SCIENTIFIC SYSTEMS, INC. | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2006 to 2010 |
Source NIH RePORTER
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/NCT00089505
GET https://conductscience.org/api/trials/v1/NCT00089505/results?page=2