Pregnancy outcomes and birth defects from an antiretroviral drug safety study of women in South Africa and Zambia.

Objective: To evaluate the safety of combination antiretroviral therapy (ART) in conception and pregnancy in different health systems.

Design: A pilot ART registry to measure the prevalence of birth defects and adverse pregnancy outcomes in South Africa and Zambia.

Methods: HIV-infected pregnant women on ART prior to conception were enrolled until delivery, and their infants were followed until 1 year old.