Trial · NCT00074412
Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
NCT00074412, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2013-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding. Trials, record NCT00074412. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00074412
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
- NCT number
- NCT00074412
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,026 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections
- Interventions
- Nevirapine, Nevirapine placebo
- First posted
- 2003-12-15
- Last updated
- 2023-02-16
- Results first posted
- 2013-09-16
- Limitations and caveats
The rate of maternal highly active antiretroviral therapy use was higher than expected in our study. Thus there were fewer infant infections which decreased the power to detect differences in HIV transmission risks between study groups.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study | At Month 6 | |
| Primary | Frequency and Severity of Adverse Reactions Among Participating Infants | 6 weeks through 18 months | For those infants who were randomized at 6 weeks and who initiated study drug we looked at the frequency and severity of adverse reactions through 18 months of study. The severity of all AEs was graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. The term severity is described as the intensity grade or level for specific event (i.e. mild, moderate, severe, or life-threatening). Severity is not the same as seriousness. |
| Secondary | Proportion of Infants Who Are Alive and HIV-uninfected in the Two Arms | At Months 6 and 18 | |
| Secondary | Relative Rates of HIV Infection in the Two Arms | At Month 18 | |
| Secondary | Infant Survival Rates (Mortality Regardless of HIV Infection) in the Two Arms | At Month 18 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study | At Month 6 | All infants who were randomly allocated to either treatment or placebo at 6 weeks of age under version 3.0 of the protocol were included in the analysis of the primary endpoint, HIV infection at 6 months. 127/1700 infants were enrolled but excluded from randomization at 6 weeks for various reasons as mentioned in the flow-through. | participants | NUMBER |
| PRIMARY | Frequency and Severity of Adverse Reactions Among Participating Infants | 6 weeks through 18 months | A total of 1519 infants, 758 in the NVP arm and 761 in the placebo arm, initiated study product and were thus included in the analysis for the frequency and severity of adverse reactions. | Number of Adverse Events | NUMBER |
| SECONDARY | Proportion of Infants Who Are Alive and HIV-uninfected in the Two Arms | At Months 6 and 18 | There were 1522 infants randomized at 6 weeks of birth to either the extended Nevirapine arm (759) or the placebo arm (763). | participants | NUMBER |
| SECONDARY | Relative Rates of HIV Infection in the Two Arms | At Month 18 | A total of 1527 infants were randomized to either placebo or extended NVP. 5 of these infants were later found to be infected at the time of randomization (2 in NVP and 3 in Placebo). Thus, only 1522 infants were included in the analysis. | participants | NUMBER |
| SECONDARY | Infant Survival Rates (Mortality Regardless of HIV Infection) in the Two Arms | At Month 18 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study | Nevirapine | # of HIV infections at 6 months | 8 | 0.3 to 1.9 | participants |
| HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study | Placebo | # of HIV infections at 6 months | 18 | 1.3 to 3.6 | participants |
| HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study | Nevirapine | # of Infants at risk for HIV infection at 6 months | 700 | participants | |
| HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study | Placebo | # of Infants at risk for HIV infection at 6 months | 699 | participants | |
| Frequency and Severity of Adverse Reactions Among Participating Infants | Nevirapine | Death | 26 | Number of Adverse Events | |
| Frequency and Severity of Adverse Reactions Among Participating Infants | Placebo | Death | 30 | Number of Adverse Events | |
| Frequency and Severity of Adverse Reactions Among Participating Infants | Nevirapine | Life-Threatening | 87 | Number of Adverse Events | |
| Frequency and Severity of Adverse Reactions Among Participating Infants | Placebo | Life-Threatening | 87 | Number of Adverse Events | |
| Frequency and Severity of Adverse Reactions Among Participating Infants | Nevirapine | Severe | 375 | Number of Adverse Events | |
| Frequency and Severity of Adverse Reactions Among Participating Infants | Placebo | Severe | 332 | Number of Adverse Events |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 763 | |
| Overall Study | STARTED | Nevirapine | 759 | |
| Overall Study | Week 8 Visit | Placebo | 759 | |
| Overall Study | Week 8 Visit | Nevirapine | 759 | |
| Overall Study | Month 3 Visit | Placebo | 759 | |
| Overall Study | Month 3 Visit | Nevirapine | 755 | |
| Overall Study | Month 4 Visit | Placebo | 758 | |
| Overall Study | Month 4 Visit | Nevirapine | 752 | |
| Overall Study | Month 5 Visit | Placebo | 756 | |
| Overall Study | Month 5 Visit | Nevirapine | 750 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events154
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 | Anaemia | Blood and lymphatic system disorders | Nevirapine | 42 | 758 | 48 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 51 | 761 | 55 |
| other | Conjunctivitis | Eye disorders | Nevirapine | 62 | 758 | 66 |
| other | Conjunctivitis | Eye disorders | Placebo | 43 | 761 | 53 |
| other | Conjunctivitis bacterial | Infections and infestations | Nevirapine | 76 | 758 | 86 |
| other | Conjunctivitis bacterial | Infections and infestations | Placebo | 72 | 761 | 80 |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Nevirapine | 55 | 758 | 60 |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Placebo | 37 | 761 | 44 |
| other | Diarrhoea | Gastrointestinal disorders | Nevirapine | 57 | 758 | 63 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 55 | 761 | 65 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nevirapine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Nevirapine | 614 | 758 |
| Total, other adverse events | Placebo | 618 | 761 |
| Total, serious adverse events | Nevirapine | 152 | 758 |
| Total, serious adverse events | Placebo | 141 | 761 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Nevirapine vs Placebo: serious adverse events |
Source 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/NCT00074412
GET https://conductscience.org/api/trials/v1/NCT00074412/results?page=2