Status:
COMPLETED
Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Centers for Disease Control and Prevention
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
18-54 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if extended antiretroviral regimens given to the infant during the first 14 weeks of age would decrease breast milk transmission of HIV.
Detailed Description
This is a three-arm randomized, open label, clinical trial to evaluate the effectiveness of two extended regimens of antiretrovirals compared to infant single dose nevirapine plus AZT given twice dail...
Eligibility Criteria
Inclusion
- Had given birth within the last 24 hours
- Ability and willingness to give informed consent for HIV testing and enrollment into the study
- Willing to receive HIV results
- HIV infected
- Planning to deliver or had given birth at the study clinics
- Willing to come back for follow-up visits for 2 years postnatally
- Resident of Blantyre city or its suburbs
Exclusion
- HIV negative
- Women with discordant HIV results
- Women who indicate that they will not breastfeed at time of delivery
- Inability or unwillingness to follow any of the inclusion requirements
- Newborn with life-threatening condition
- Women who previously enrolled in this study and have a second pregnancy cannot reenroll
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
3300 Patients enrolled
Trial Details
Trial ID
NCT00115648
Start Date
April 1 2004
End Date
October 1 2009
Last Update
March 7 2014
Active Locations (1)
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1
College of Medicine
Blantyre, Malawi, 1331