Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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 tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or emtricitabine/TDF (FTC/TDF) given at the time of labor to HIV infected pregnant women and to their newborn infants.
Key facts
- Study ID
- NCT00076791
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 66
- Starts
- 2004-03-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2021-11-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Children's National Med. Ctr. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
- Washington Hosp. Ctr. NICHD CRS — Washington D.C., District of Columbia, United States
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
- Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program — Chicago, Illinois, United States
- Children's Hospital of Michigan NICHD CRS — Detroit, Michigan, United States
- NJ Med. School CRS — Newark, New Jersey, United States
- Nyu Ny Nichd Crs — New York, New York, United States
- Bronx-Lebanon Hosp. IMPAACT CRS — The Bronx, New York, United States
- Hahnemann Univ. Hosp. — Philadelphia, Pennsylvania, United States
- Regional Med. Ctr. at Memphis — Memphis, Tennessee, United States
- St. Jude/UTHSC CRS — Memphis, Tennessee, United States
- San Juan City Hosp. PR NICHD CRS — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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