Phase 3
N=1,522
Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00074412 ↗Enrolled (actual)
1,522
Serious AEs
19.3%
Results posted
Sep 2013
Primary outcome: Primary: HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study — 8; 18; 700; 699 participants — p=0.049
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nevirapine (Drug); Nevirapine placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study |
8; 18; 700; 699 | 0.049 sig |
| PRIMARY Frequency and Severity of Adverse Reactions Among Participating Infants |
26; 30; 87; 87; 375; 332 | — |
| SECONDARY Proportion of Infants Who Are Alive and HIV-uninfected in the Two Arms |
689; 683; 629; 616 | 0.274 |
| SECONDARY Relative Rates of HIV Infection in the Two Arms |
16; 23; 664; 663 | 0.280 |
| SECONDARY Infant Survival Rates (Mortality Regardless of HIV Infection) in the Two Arms |
26; 30; 678; 684 | 0.805 |
Summary
The many benefits of breastfeeding are well documented. However, because of the risk of mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there is considerable concern over the practice, especially in developing countries. The purpose of this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP) in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South Africa, Tanzania, Uganda, and Zimbabwe.
Eligibility Criteria
Note: As of 08/10/07, the arm assignments for current and new participants have changed. Please see the above description for this trial for more information.
Inclusion Criteria for Mothers:
- 18 years of age or older
- HIV infected
- In third trimester of pregnancy, or at most 3 days post-delivery
- If baby is not yet born, planning to deliver at a facility where the study is being conducted
- Plan to breastfeed
Exclusion Criteria for Mothers:
- Complications with this pregnancy
- Serious medical condition that would interfere with the study (e.g., that would prevent breastfeeding or adherence to the follow-up schedule), as judged by the on-site clinician
Inclusion Criteria for Infants:
- Born to an HIV infected mother who is eligible for the study
- Weighed at least 2000 grams (4.4 lbs) at birth
- Blood sample obtained from the infant for HIV-1 DNA PCR, CBC with differential, and ALT
- Infants in a multiple birth are eligible only if both/all infants are eligible for the study and assigned to the same study group
- Able to breastfeed (e.g., mother and infant alive with no condition apparent that would prevent breastfeeding)
Exclusion Criteria for Infants:
- HIV DNA PCR positive at birth
- ALT of Grade 2 or higher at birth
- Hemoglobin, absolute neutrophil count, or platelet count of Grade 3 or higher at birth
- Skin rash of Grade 2B (urticaria), Grade 3, or above
- Confirmed or suspected clinical hepatitis
- Serious illness or condition that would interfere with compliance with study procedures
Data sourced from ClinicalTrials.gov (NCT00074412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.