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Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding

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ClinicalTrials.gov Identifier: NCT00074412
Recruitment Status : Completed
First Posted : December 15, 2003
Results First Posted : September 16, 2013
Last Update Posted : September 16, 2013
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Prevention
Condition HIV Infections
Interventions Drug: Nevirapine
Drug: Nevirapine placebo
Enrollment 2026
Recruitment Details HIV-infected pregnant women were recruited from antenatal clinics at DAIDS Clinical Trials Sites in Zimbabwe, South Africa, Uganda & Tanzania between May 14, 2008 & January 20th 2010. 1700 mother/infant pairs were enrolled & infants were given daily doses of Nevirapine for 6 weeks at which point there were randomized to placebo or extended NVP.
Pre-assignment Details Infants were excluded from randomization if in first 42 days: had a positive HIV-1 DNA PCR, breastfeeding was discontinued, never initiated or permanently discontinued open-label NVP, certain graded abnormal labs, skin rash grade2B or higher, clinical hepatitis, serious illness/condition that prevented compliance, or use of rifampin/ketoconazole.
Arm/Group Title Placebo Nevirapine
Hide Arm/Group Description For infants: extended treatment with NVP placebo For infants: extended treatment with NVP
Period Title: Overall Study
Started 763 [1] 759 [1]
Week 8 Visit 759 759
Month 3 Visit 759 755
Month 4 Visit 758 752
Month 5 Visit 756 750
Month 6 Visit 748 748
Month 9 Visit 741 741
Month 12 Visit 733 735
Completed 681 [2] 675 [2]
Not Completed 82 84
Reason Not Completed
Death             30             26
Lost to Follow-up             52             58
[1]
Number of infants randomized at 6 weeks.
[2]
Number of infants who completed final 18 month visit: out of 733 infants who were expected.
Arm/Group Title Nevirapine Placebo Total
Hide Arm/Group Description For infants: extended treatment with NVP For infants: extended treatment with NVP placebo Total of all reporting groups
Overall Number of Baseline Participants 759 763 1522
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 759 participants 763 participants 1522 participants
<=18 years
759
 100.0%
763
 100.0%
1522
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 759 participants 763 participants 1522 participants
Ambiguous 1 0 1
Male 363 398 761
Female 395 365 760
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 759 participants 763 participants 1522 participants
Tanzania 98 99 197
Uganda 259 261 520
South Africa 171 171 342
Zimbabwe 231 232 463
Categorical Infant Birthweight (g)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 759 participants 763 participants 1522 participants
Missing 0 1 1
2000-2499 50 52 102
2500-2999 214 211 425
3000-3499 329 336 665
>=3500 166 163 329
1.Primary Outcome
Title HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study
Hide Description [Not Specified]
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nevirapine Placebo
Hide Arm/Group Description:
For infants: extended treatment with NVP
For infants: extended treatment with NVP Placebo
Overall Number of Participants Analyzed 759 763
Measure Type: Number
Unit of Measure: participants
# of HIV infections at 6 months 8 18
# of Infants at risk for HIV infection at 6 months 700 699
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier Method
Comments [Not Specified]
Method of Estimation Estimation Parameter 6 month Rate of Cum. HIV Infection (%)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.3 to 1.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier Method
Comments [Not Specified]
Method of Estimation Estimation Parameter 6 month Rate of Cum. HIV Infection (%)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
1.3 to 3.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nevirapine, Placebo
Comments Assuming the cumulative HIV infection rate in placebo group would be 4.2% (2.6 at 6 wk. & 6.7 at 6 mon.), we estimated 1500 mother/infant pairs would provide 90% power to detect a reduction in HIV infection from 4.2% to 1.4% at 6 mon. with a Pearson χ² test statistic and a one-sided false positive error rate of 0.025. Rate of cumulative infection was calculated using Kaplan-Meier method and rates between extended NVP group and placebo were done with the Z statistic.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments P-value has not been adjusted for interim analysis or multiple testing. A priori threshold for statistical significance was 0.05.
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Z statistic
Estimated Value 1.973
Estimation Comments [Not Specified]
2.Primary Outcome
Title Frequency and Severity of Adverse Reactions Among Participating Infants
Hide Description 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.
Time Frame 6 weeks through 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nevirapine Placebo
Hide Arm/Group Description:
For infants: extended treatment with NVP
For infants: extended treatment with NVP placebo
Overall Number of Participants Analyzed 758 761
Overall Number of Units Analyzed
Type of Units Analyzed: Adverse Events
2014 1964
Measure Type: Number
Unit of Measure: Number of Adverse Events
Death 26 30
Life-Threatening 87 87
Severe 375 332
Moderate 694 677
Mild 832 838
3.Secondary Outcome
Title Proportion of Infants Who Are Alive and HIV-uninfected in the Two Arms
Hide Description [Not Specified]
Time Frame At Months 6 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
There were 1522 infants randomized at 6 weeks of birth to either the extended Nevirapine arm (759) or the placebo arm (763).
Arm/Group Title Nevirapine Placebo
Hide Arm/Group Description:
For infants: extended treatment with NVP
For infants: extended treatment with NVP placebo
Overall Number of Participants Analyzed 759 763
Measure Type: Number
Unit of Measure: participants
Number of Infants Alive and HIV-free at 6 months 689 683
Number of Infants Alive and HIV-free at 18 months 629 616
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine
Comments The cumulative rate of HIV-free survival at 6 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Cum. Rate of HIV-free Survival 6mon (%)
Estimated Value 97.7
Confidence Interval (2-Sided) 95%
96.6 to 98.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments The cumulative rate of HIV-free survival at 6 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Cum. Rate of HIV-free Survival 6mon (%)
Estimated Value 96.8
Confidence Interval (2-Sided) 95%
95.5 to 98.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nevirapine, Placebo
Comments The cumulative rates of HIV-free survival at 6 months were compared between the two groups using a Z-statistic.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.274
Comments P-value was not adjusted for interim analysis or multiple testing.
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Z statistic
Estimated Value 1.095
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Nevirapine
Comments The cumulative rate of HIV-free survival at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while 95% confidence intervals were calculated using Greenwood's formula.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Cum. Rate of HIV-free Survival 18mon (%)
Estimated Value 94.5
Confidence Interval (2-Sided) 95%
92.9 to 96.2
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo
Comments The cumulative rate of HIV-free survival at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Cum. Rate of HIV-free Survival 18mon (%)
Estimated Value 93.3
Confidence Interval (2-Sided) 95%
91.5 to 95.1
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Nevirapine, Placebo
Comments The cumulative rates of HIV-free survival at 18 months were compared between the two groups using a Z statistic.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.323
Comments P-value was not adjusted for interim analysis or multiple testing.
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Z statistic
Estimated Value 0.988
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Relative Rates of HIV Infection in the Two Arms
Hide Description [Not Specified]
Time Frame At Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nevirapine Placebo
Hide Arm/Group Description:
For infants: extended treatment with NVP
For infants: extended treatment with NVP placebo
Overall Number of Participants Analyzed 759 763
Measure Type: Number
Unit of Measure: participants
# of infants with HIV infection at 18 months 16 23
# of infants @ risk for HIV infection at 18 months 664 663
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine
Comments The cumulative rate of HIV infection at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier Method
Comments [Not Specified]
Method of Estimation Estimation Parameter 18 mon. Rate of Cum HIV Infection (%)
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
1.1 to 3.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments The cumulative rate of HIV infection at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier Method
Comments [Not Specified]
Method of Estimation Estimation Parameter 18 mon. Rate of Cum. HIV Infection (%)
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
1.9 to 4.4
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nevirapine, Placebo
Comments The cumulative rates of HIV infection at 18 months were calculated using the Kaplan-Meier method and were compared between arms using a Z statistic.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.280
Comments P-value was not adjusted for interim analysis or multiple testing.
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Z statistic
Estimated Value 1.081
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Infant Survival Rates (Mortality Regardless of HIV Infection) in the Two Arms
Hide Description [Not Specified]
Time Frame At Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nevirapine Placebo
Hide Arm/Group Description:
For infants: extended treatment with NVP
For infants: extended treatment with NVP placebo
Overall Number of Participants Analyzed 759 763
Measure Type: Number
Unit of Measure: participants
# Infant Deaths at 18 months 26 30
# Infants at risk of death at 18 months 678 684
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Cumulative Mortality Rate at 18mon (%)
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
2.0 to 7.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Cumulative Mortality Rate at 18mon (%)
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
2.7 to 5.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nevirapine, Placebo
Comments The cumulative rates of mortality at 6 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z-statistic.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.805
Comments P-value was not adjusted for interim analysis or multiple testing
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Z statistic
Estimated Value -0.247
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Nevirapine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Cumulative Mortality Rate at 6mon (%)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.4 to 2.0
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Cumulative Mortality Rate at 6mon (%)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.3 to 1.8
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Nevirapine, Placebo
Comments The cumulative mortality rates at 18 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z statistic.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.719
Comments P-value was not adjusted for interim analysis or multiple testing.
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Z statistic
Estimated Value -0.360
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Nevirapine, Placebo
Comments We compared the cumulative mortality rates, as calculated using Kaplan-Meier, between the two study groups over all 18 months of the study follow-up using a log-rank test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.611
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Frequency and Duration of Maternal Plasma and Breast Milk NVP-resistant HIV Strains and the Relationship With HIV Transmission
Hide Description [Not Specified]
Time Frame Throughout study
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Relationship Between Maternal Plasma and Breast Milk RNA Levels and the Risk of MTCT
Hide Description [Not Specified]
Time Frame Throughout study
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Frequency and Duration of NVP-resistant HIV Strains in Plasma of HIV-infected Infants
Hide Description [Not Specified]
Time Frame Throughout study
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Rates of Disease Progression as Defined by CD4 Counts, HIV-1 RNA PCR, and Mortality in Infected Infants in the Two Arms
Hide Description [Not Specified]
Time Frame Throughout study
Outcome Measure Data Not Reported
10.Secondary Outcome
Title NVP Concentrations in Infants Determined to be HIV-infected and in a Sample of HIV-uninfected Infants
Hide Description Samples for NVP concentration were selected from the Version 3.0 infants who were randomized to NVP at 6 weeks and whose mothers were not on 3 or more antiretrovirals at the time of randomization. All infants HIV-infected by 6 months who met this criteria were selected and matched to HIV-uninfected infants who also met this criteria in a 1:3 ratio. NVP concentrations were measured by high liquid chromatographic/mass spectroscopy from the aforementioned infants plasma samples collected at week 8 and month 3. Median NVP concentrations were compared
Time Frame Week 8 and Month 3
Outcome Measure Data Not Reported
Time Frame Regardless of seriousness, severity or relatedness all AEs occurring in infants after enrollment (birth) and throughout the duration of the study (18 months) must be recorded.
Adverse Event Reporting Description Non-serious adverse events occurring in an infant between randomization and 8 months of life will be collected on a case report form. Further, Serious AEs and AEs that meet the DAIDS expedited reporting criteria will be reported through case report forms throughout the entire 18 month follow-up period.
 
Arm/Group Title Nevirapine Placebo
Hide Arm/Group Description For infants: extended treatment with NVP For infants: extended treatment with NVP placebo
All-Cause Mortality
Nevirapine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nevirapine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   152/758 (20.05%)      141/761 (18.53%)    
Blood and lymphatic system disorders     
Aneamia  1  1/758 (0.13%)  1 4/761 (0.53%)  4
Cardiac disorders     
Cardipulmonary failure  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Congenital, familial and genetic disorders     
Cerebral palsy  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Congenital absence of bile ducts  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Sickle cell anaemia  1  3/758 (0.40%)  4 2/761 (0.26%)  2
Sickle cell anaemia with crisis  1  1/758 (0.13%)  1 1/761 (0.13%)  1
Eye disorders     
Blindness  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Gastrointestinal disorders     
Diarrhoea  1  6/758 (0.79%)  6 5/761 (0.66%)  5
Gastrointestinal haemorrhage  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Inguinal hernia  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Intussusception  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Vomiting  1  0/758 (0.00%)  0 1/761 (0.13%)  1
General disorders     
Death  1  4/758 (0.53%)  4 2/761 (0.26%)  2
Oedema  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Pyrexia  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Sudden infant death syndrome  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Hepatobiliary disorders     
Hyperbilirubinaemia  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Immune system disorders     
Anaphylactic reaction  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Infections and infestations     
Abscess  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Abscess bacterial  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Arthritis bacterial  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Bacteraemia  1  1/758 (0.13%)  1 1/761 (0.13%)  1
Bronchiolitis  1  2/758 (0.26%)  2 4/761 (0.53%)  7
Bronchopneumonia  1  18/758 (2.37%)  19 20/761 (2.63%)  23
Cellulitis  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Cerebral malaria  1  1/758 (0.13%)  2 0/761 (0.00%)  0
Febrile infection  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Gastroenteritis  1  45/758 (5.94%)  50 50/761 (6.57%)  58
Gastroenteritis shigella  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Giardiasis  1  0/758 (0.00%)  0 1/761 (0.13%)  2
Injection site abscess  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Lobar pneumonia  1  3/758 (0.40%)  3 0/761 (0.00%)  0
Lower respiratory tract infection  1  6/758 (0.79%)  6 1/761 (0.13%)  2
Malaria  1  42/758 (5.54%)  50 34/761 (4.47%)  40
Measles  1  3/758 (0.40%)  3 3/761 (0.39%)  3
Meningitis  1  2/758 (0.26%)  2 3/761 (0.39%)  3
Meningitis bacterial  1  3/758 (0.40%)  3 0/761 (0.00%)  0
Pericarditis tuberculous  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Plasmodium falciparum infection  1  1/758 (0.13%)  1 1/761 (0.13%)  1
Pneumocystis jiroveci pneumonia  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Pneumonia  1  20/758 (2.64%)  21 29/761 (3.81%)  29
Pneumonia bacterial  1  2/758 (0.26%)  2 2/761 (0.26%)  2
Pulmonary tuberculosis  1  2/758 (0.26%)  2 2/761 (0.26%)  2
Respiratory tract infection  1  2/758 (0.26%)  2 0/761 (0.00%)  0
Sepsis  1  5/758 (0.66%)  5 9/761 (1.18%)  12
Sepsis neonatal  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Tonsilitis  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Upper respiratory tract infection  1  0/758 (0.00%)  0 1/761 (0.13%)  1
Urinary tract infection  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Injury, poisoning and procedural complications     
Chemical poisoning  1  1/758 (0.13%)  1 1/761 (0.13%)  1
Femur fracture  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Head injury  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Thermal burn  1  1/758 (0.13%)  1 2/761 (0.26%)  2
Traumatic shock  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  1/758 (0.13%)  1 1/761 (0.13%)  1
Haemoglobin decreased  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Hepatic enzyme increased  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Neutrophil count decreased  1  1/758 (0.13%)  1 2/761 (0.26%)  2
Metabolism and nutrition disorders     
Electrolyte imbalance  1  0/758 (0.00%)  0 1/761 (0.13%)  2
Kwashiorkor  1  5/758 (0.66%)  5 9/761 (1.18%)  9
Malnutrition  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Marasmus  1  3/758 (0.40%)  3 4/761 (0.53%)  5
Nervous system disorders     
Febrile convulsion  1  5/758 (0.66%)  5 0/761 (0.00%)  0
Hydrocephalus  1  1/758 (0.13%)  1 0/761 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  1/758 (0.13%)  1 2/761 (0.26%)  2
Pneumonia aspiration  1  2/758 (0.26%)  2 0/761 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nevirapine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   614/758 (81.00%)      618/761 (81.21%)    
Blood and lymphatic system disorders     
Anaemia  1  42/758 (5.54%)  48 51/761 (6.70%)  55
Eye disorders     
Conjunctivitis  1  62/758 (8.18%)  66 43/761 (5.65%)  53
Gastrointestinal disorders     
Diarrhoea  1  57/758 (7.52%)  63 55/761 (7.23%)  65
Infections and infestations     
Conjunctivitis bacterial  1  76/758 (10.03%)  86 72/761 (9.46%)  80
Gastroenteritis  1  188/758 (24.80%)  268 208/761 (27.33%)  288
Malaria  1  122/758 (16.09%)  164 112/761 (14.72%)  160
Oral candidiasis  1  97/758 (12.80%)  121 79/761 (10.38%)  93
Upper respiratory infection  1  135/758 (17.81%)  159 187/761 (24.57%)  223
Investigations     
Haemoglobin decreased  1  73/758 (9.63%)  76 64/761 (8.41%)  67
Neutrophil count decreased  1  145/758 (19.13%)  181 121/761 (15.90%)  153
Skin and subcutaneous tissue disorders     
Dermatitis atopic  1  55/758 (7.26%)  60 37/761 (4.86%)  44
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In accordance with the Clinical Trial Agreement between NIAID (DAIDS) & company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review & comment. The publication or other disclosure can be delayed for up to thirty additional business days for manuscripts & five business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Name/Title: Statistical Research Associate
Organization: Statistical Center for HIV/AIDS Research and Prevention
Phone: 2066677524
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00074412     History of Changes
Other Study ID Numbers: HPTN 046
10142 ( Registry Identifier: DAIDS ES )
First Submitted: December 11, 2003
First Posted: December 15, 2003
Results First Submitted: May 30, 2013
Results First Posted: September 16, 2013
Last Update Posted: September 16, 2013