Status:
COMPLETED
Nevirapine Study for the Prevention of Maternal-Infant HIV Transmission in Uganda
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The increase in pediatric HIV infection has a substantial impact on childhood mortality in the developing world. A number of recent studies suggest that as many as half or more of mother-to-child HIV ...
Detailed Description
There is an urgent need to find safe, effective means of preventing mother-to-child-transmission (MTCT) of HIV that can be used in developing countries. One of the greatest obstacles to prevention in ...
Eligibility Criteria
Inclusion
- Pregnant between 32-36 weeks estimated gestation
- HIV Infected
- Intent to breastfeed infant
- Certain laboratory criteria. More information on this criterion can be found in the protocol.
Exclusion
- Sensitivity to immune globulin preparations or any benzodiazepine
- Clinically significant disease, as determined by the investigator, that would compromise the ability of the participant to complete the study requirements
- Currently receiving antiretroviral therapy (other than the intrapartum NVP or other peripartum regimens)
- Participation in any HIV vaccine trials
- History of cytotoxic chemotherapy within one month of study entry
- Uncontrolled hypertension
- Chronic alcohol or illicit drug use
- History of non-compliance with visits or medication
- Women who become pregnant again during study follow-up will not be eligible for re-enrollment in the trial
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
722 Patients enrolled
Trial Details
Trial ID
NCT00639938
Start Date
July 1 2004
End Date
July 1 2007
Last Update
April 2 2008
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