Status:
COMPLETED
Breastfeeding, Antiretroviral, and Nutrition Study
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
University of North Carolina, Chapel Hill
Kamuzu Central Hospital
Conditions:
HIV Infections
Eligibility:
All Genders
14+ years
Phase:
PHASE3
Brief Summary
This is a comparative clinical trial among HIV-infected women and their infants to determine: 1. the benefit of nutritional supplementation given to women during breastfeeding 2. the benefit and safe...
Detailed Description
This study addresses the complex issues of HIV related maternal morbidity, mortality, and postnatal HIV transmission during breastfeeding and weaning in resource-poor countries. Objectives include ass...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Recruitment and primary eligibility criteria:
- Age \> 14 years.
- Ability to give informed assent or consent.
- Evidence of HIV infection, as documented by 2 positive ELISA antibody tests; or 1 positive ELISA, and 1 Western Blot; or 2 separate concurrent rapid tests.
- Currently pregnant (with a single or multiple fetuses).
- Gestation \< 30 weeks at referral from 'Call to Action' Program
- No serious current complications of pregnancy.
- Intention to breastfeed.
- Intention to deliver at the institution at which the study is based.
- Not previously enrolled in this study for an earlier pregnancy.
- Other than HIV, no active serious infection, such as tuberculosis or other potentially serious illnesses.
- No previous use of antiretrovirals including the HIVNET 012 regimen.
- Mother's CD4 count \> 250 cells/uL determined in the antenatal clinic.
- Mother's ALT \< 2.5 x ULN (upper limit of normal) determined in the antenatal clinic
- Secondary eligibility criteria and treatment assignment:
- Mother who delivers outside of the institution at which the study is based must present with her infant to the study site within 36 hours of delivery.
- Mother accepts nevirapine and zidovudine+lamivudine 7-day regimen for herself and her infant.
- Infant birth weight \> 2000 g.
- No severe congenital malformations or other condition(s) not compatible with life.
- Based on clinical assessment, no maternal condition which would preclude the start of the study intervention.
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
2369 Patients enrolled
Trial Details
Trial ID
NCT00164736
Start Date
March 1 2004
End Date
January 1 2010
Last Update
April 23 2010
Active Locations (1)
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1
Kamuzu Central Hospital, Bottom Hospital
Lilongwe, Malawi