Status:
COMPLETED
Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 conc...
Detailed Description
Breastfeeding provides general health, growth, and development benefits to an infant and significantly decreases the risk of certain acute and chronic diseases. Breastfeeding also decreases financial ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
2026 Patients enrolled
Trial Details
Trial ID
NCT00074412
Start Date
January 1 2007
End Date
November 1 2011
Last Update
February 16 2023
Active Locations (5)
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1
CAPRISA Umlazi CRS
Umlazi, KwaZulu-Natal, South Africa
2
Muhimbili University of Health and Allied Sciences (MUHAS) CRS
Dar es Salaam, Tanzania
3
Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS
Kampala, Mpigi, Uganda
4
Seke North CRS
Chitungwiza, Zimbabwe