Status:
COMPLETED
Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Conditions:
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal transmission) become infected during labor and delivery. The purpose of this study is to test the safety and tol...
Detailed Description
The majority of perinatally infected infants are infected during the labor and delivery process, but recent studies suggest that additional factors, such as postexposure prophylaxis, are likely to be ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Mothers:
- HIV infected
- 34 weeks or more (third trimester) into pregnancy at study screening
- Have access to a participating AIDS clinical trial unit (ACTU) and are willing to be followed at location for the duration of the study
- Exclusion Criteria for Mothers:
- Prior treatment with TDF, including coformulated drugs that contain TDF, during current pregnancy
- Active opportunistic infection and/or serious bacterial infection at time of study entry
- Certain abnormal laboratory values at study screening
- Chronic malabsorption or chronic diarrhea
- Certain medical or obstetrical complications during the current pregnancy
- Fetal abnormalities as measured by ultrasound screening performed at 18 weeks into pregnancy or later
- Intend to breastfeed
- Current alcohol abuse or use of illicit substances
- Participation in any other therapeutic or vaccine perinatal treatment trial during the current pregnancy, unless given permission by the protocol chairs
- Require certain medications
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00076791
Start Date
March 1 2004
End Date
March 1 2011
Last Update
November 1 2021
Active Locations (12)
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1
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States, 20010
2
Washington Hosp. Ctr. NICHD CRS
Washington D.C., District of Columbia, United States, 20010
3
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33136
4
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
Chicago, Illinois, United States, 60608