Status:
RECRUITING
Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant People.
Lead Sponsor:
Syneos Health
Collaborating Sponsors:
AbbVie
Alvogen Inc.
Conditions:
HIV Infections
Hepatitis B
Eligibility:
FEMALE
12-60 years
Brief Summary
The purpose of the Antiretroviral Pregnancy Registry (Registry) is to detect any major teratogenic effect involving any of the Registry drugs when administered to pregnant people. Registration is volu...
Detailed Description
The following antiretroviral drugs are followed by the Antiretroviral Pregnancy Registry (APR, Registry) to detect any major teratogenic effect when administered to pregnant people: abacavir (ZIAGEN®,...
Eligibility Criteria
Inclusion
- Eligibility Ages Eligible for Study: People of childbearing potential
- Country of origin of report
- Documentation that the registry drug was taken during pregnancy
- Sufficient information to determine if the pregnancy is being prospectively or retrospectively registered
- Date the pregnancy was registered
- Source of report (patient or health care provider)
- Whether the pregnancy outcome is already known or delivery is still pending
- Timing of the prenatal exposure to the registry medication (no broader than which trimester)
- Sufficient patient identifier relevant to reporter to allow for follow-up
- Was patient involved in a study at the time of prenatal exposure
- Full reporter contact information (name, address, etc.)
Exclusion
- • People who were not exposed to registry medications during pregnancy
Key Trial Info
Start Date :
January 1 1989
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2099
Estimated Enrollment :
24258 Patients enrolled
Trial Details
Trial ID
NCT00404989
Start Date
January 1 1989
End Date
January 1 2099
Last Update
April 1 2025
Active Locations (1)
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1
Registry Coordinating Center
Wilmington, North Carolina, United States, 28403