Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
To prevent mother-to-child transmission (MTCT) of HIV in resource-limited countries, a simple
yet effective treatment plan is needed. Tenofovir disoproxil fumarate (TDF) is an anti-HIV
drug approved for use in the United States for the treatment of HIV infected adults. The
purpose of this study is to determine the safety, tolerability, and blood levels of TDF in
HIV infected pregnant women and their babies. The study will be conducted at sites in Malawi
and Brazil.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Mental Health (NIMH) National Institute on Drug Abuse (NIDA)