Status:
COMPLETED
Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The purpose of this study is to determine whether giving infants of HIV infected mothers the anti-HIV drug nev...
Detailed Description
The use of antiretroviral therapy during late pregnancy, intrapartum, and immediately postpartum prevents a high proportion of vertical transmission. Potential means of decreasing HIV transmission thr...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- HIV infection, documented on two separate specimens
- Estimated gestational age at enrollment of 32 weeks or more as indicated by last menstrual cycle and fundal height
- Permanent residency in Addis Ababa
- Plan to deliver at a hospital affliated with the study (Tikur Anbessa Hospital, Gandhi hospital, or St. Paul's Hospital)
- Hemoglobin \>= 7.5 gm/dl within 4 weeks prior to study entry
- Serum glutamic pyruvic transaminase (SGPT) \< 5 times upper limit of normal within 4 weeks prior to study entry
- Serum creatinine \< 1.5 mg/dl within 4 weeks prior to study entry
- Consent form signed by the mother and, when possible, by the father, prior to the onset of labor
Exclusion
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
775 Patients enrolled
Trial Details
Trial ID
NCT00074399
Start Date
February 1 2001
End Date
April 1 2007
Last Update
August 7 2009
Active Locations (1)
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1
Tikur Anbessa Hospital
Addis Ababa, Ethiopia