Antiretroviral therapy (ART) has had a dramatic impact in the reduction of maternal to fetal HIV transmission in the last decade. Use of ART to treat maternal HIV infection during pregnancy or reducing mother-to-child transmission has become standard of care. However, prevention of HIV transmission requires exposing the pregnant mother and her offspring to potent ART medications and increasingly complex treatment regimes. Yet, the fetal safety of currently approved ART medications is largely unknown. Thus, there is need to evaluate the fetal toxicity of specific ART strategies. Given the overwhelming benefits of ART in HIV transmission prevention, the clinically relevant question revolve around timing (e.g., when to initiate therapy) and specific ART regime selection (e.g., which combination of drugs). The major aim of this proposal is to contribute fetal safety information to the development of evidence-based recommendations for the management of HIV-infected pregnant women that will assist clinicians and patients in their decision making process. We propose to evaluate the risk of congenital malformations and other adverse pregnancy outcomes following antenatal exposure to ART in a prospective cohort of pregnant women.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD056940-02
Application #
7900957
Study Section
AIDS Clinical Studies and Epidemiology Study Section (ACE)
Program Officer
Shirazi, Yasaman
Project Start
2009-08-01
Project End
2012-05-31
Budget Start
2010-06-01
Budget End
2012-05-31
Support Year
2
Fiscal Year
2010
Total Cost
$1,126,500
Indirect Cost
Name
Harvard University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
149617367
City
Boston
State
MA
Country
United States
Zip Code
02115
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Phiri, Kelesitse; Fischer, Michael A; Mogun, Helen et al. (2014) Trends in antiretroviral drug use during pregnancy among HIV-infected women on medicaid: 2000-2007. AIDS Patient Care STDS 28:56-65
Phiri, Kelesitse; Hernandez-Diaz, Sonia; Dugan, Kate B et al. (2014) First trimester exposure to antiretroviral therapy and risk of birth defects. Pediatr Infect Dis J 33:741-6
Hernan, Miguel A; Hernandez-Diaz, Sonia (2012) Beyond the intention-to-treat in comparative effectiveness research. Clin Trials 9:48-55