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Antiretroviral Pregnancy Registry (APR) for HIV and Hepatitis B

This registry is collecting information on pregnant individuals who take antiretroviral drugs for HIV or Hepatitis B. The goal is to identify any major birth defects that might be linked to these medications, such as abacavir (ZIAGEN®), atazanavir (REYATAZ®), and dolutegravir (TIVICAY®), among many others. You can join if you are a woman between 12 and 60 years old and are pregnant or of childbearing potential. Healthcare providers confidentially report information about your pregnancy and the medications you are taking, both before and after the baby is born. This helps researchers understand the safety of these drugs during pregnancy.

Study design
This is an observational study, meaning researchers are watching and collecting information rather than giving specific treatments. It aims to enroll 24,258 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00404989

Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant People.

Recruiting
Not specifiedAges 12–60Observational
Syneos Health
~24,258 participants
Updated 2025-04-01 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring

A primary outcome measure isn't published for this study.

Conditions

HIV Infections
Hepatitis B

Explore related trials

Hepatitis B InfectionHIV InfectionPregnancy

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Jessica D Albano, PhD, MPH · PRINCIPAL_INVESTIGATOR · Syneos Health

Who to contact

Taylor Cook
[email protected]
800-258-4263
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.)