Antiretroviral Pregnancy Registry (APR)-Risk of Birth Defects
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
The APR began as the 'Zidovudine in pregnancy Registry' in January 1989 and became the
'Antiretroviral Pregnancy Registry' in January, 1993. The purpose of the APR is to detect any
major teratogenic effects involving any of the Registry drugs when administered to pregnant
HIV positive women. The Registry is intended to provide an early signal of teratogenicity
associated with prenatal use of the antiretroviral drugs. The Registry collects data on
prenatal exposures to antiretroviral drugs, potential confounding factors (such as maternal
age, disease status during pregnancy), and information about the outcome of the pregnancy.
The Registry is managed by INC Research. The scientific conduct and analysis of the Registry
data are overseen by an independent Advisory Committee consisting of members from the Centers
for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), the National
Institutes of Health (NIH), and the academic sector. Registry data are obtained from
participating providers who encompass physicians in private practice as well as hospitals and
community clinics.
The registry is co-sponsored and co-funded by 26 pharmaceutical companies that manufacture
drugs used in ART.
For an updated version of the registry, please see NCT00404989.