Status:
COMPLETED
ARVs to Prevent Breastmilk HIV:Viral and Immune Responses
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Elizabeth Glaser Pediatric AIDS Foundation
Conditions:
HIV Infections
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief Summary
Identifying new approaches for preventing breastmilk transmission of HIV-1 is an important research priority. To this end, clinical trials are underway to evaluate the efficacy of HAART (zidovudine, l...
Detailed Description
This will be a randomized study comparing breastfeeding women receiving zidovudine/nevirapine (from 36 weeks to delivery/first day postpartum) to women receiving HAART (zidovudine, nevirapine, lamivud...
Eligibility Criteria
Inclusion
- The subject population is recruited from Mathare North Clinic in Nairobi, Kenya where voluntary HIV-1 counseling and testing is offered to pregnant women
- Pregnant women who test positive for HIV-1 antibody are eligible for the study if they are over 18 years of age
- At less than 32 weeks' gestation
- Have never previously been exposed to antiretroviral medications
- Agree to serial maternal blood
- Breast milk
- Infant blood draws
- Plan to live in Nairobi for at least a year after delivery.
Exclusion
- CD4 \>500 or \<200
- Not planning to live in Nairobi after delivery
- Not planning to breastfeed.
Key Trial Info
Start Date :
November 3 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00167674
Start Date
November 3 2003
End Date
April 1 2006
Last Update
January 15 2025
Active Locations (1)
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1
University of Nairobi
Nairobi, Kenya