Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant People.
APR
1 other identifier
observational
24,258
1 country
1
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 voluntary and confidential with information obtained from the health care provider. A Registry-assigned identifier allows for follow-up capability. Information on subjects is provided to the Registry prospectively (prior to the outcome of pregnancy being known) through their health care provider, with follow-up obtained from the health care provider after the outcome is determined. Providers are strongly urged to enroll their patients as early in pregnancy as possible to maximize the validity of the data. In addition, the Registry is very interested in assembling a group of providers who are willing to make a commitment to report all of their site's antiretroviral pregnancy exposures to the Registry, thereby assuring all cases can be considered prospective. Providers are encouraged to contact the Registry for more information about this group. The Registry is informed in its analysis by other data, for example, retrospective reports and clinical studies. Given the increasing number of medications and more aggressive approach to therapy, more HIV- and hepatitis B-infected people may be treated during pregnancy or become pregnant while under treatment. The paucity of data on use and infant outcomes of antiretroviral therapies during pregnancy makes this Registry an essential component of the ongoing program of epidemiologic studies of the safety of these therapies. Each year the Registry has enrolled approximately 1300-1700 pregnant people in the US exposed to antiretroviral drugs. This number represents approximately 15% of the 8,700 HIV positive people who give birth to live infants annually in the US.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 1989
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1989
CompletedFirst Submitted
Initial submission to the registry
November 27, 2006
CompletedFirst Posted
Study publicly available on registry
November 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2099
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2099
April 1, 2025
June 1, 2024
110.1 years
November 27, 2006
March 26, 2025
Conditions
Keywords
Eligibility Criteria
Pregnant people exposed to antiviral medications during pregnancy.
You may qualify if:
- 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.)
You may not qualify if:
- People who were not exposed to registry medications during pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Syneos Healthlead
- AbbViecollaborator
- Alvogen Inc.collaborator
- Amneal Pharmaceuticals, LLCcollaborator
- Apotex Corp.collaborator
- Boehringer Ingelheimcollaborator
- Bristol-Myers Squibbcollaborator
- Cipla Ltd.collaborator
- Dr. Reddy's Laboratories Limitedcollaborator
- Gilead Sciencescollaborator
- Hetero Labscollaborator
- Hikma Pharmaceuticals LLCcollaborator
- i3 Pharmaceuticals, LLCcollaborator
- Janssen Scientific Affairs, LLCcollaborator
- Lannett Company, Inc.collaborator
- Laurus Labs Limitedcollaborator
- Lupin Pharmaceuticals, Inc.collaborator
- Macleods Pharmaceuticals Ltdcollaborator
- Merck Sharp & Dohme LLCcollaborator
- Mylan Laboratoriescollaborator
- Pharmascience Inc.collaborator
- Qilu Pharmaceutical Co., Ltd.collaborator
- Sigmapharm Laboratoriescollaborator
- Strides Pharma Science Limitedcollaborator
- Teva Pharmaceuticals USAcollaborator
- ViiV Healthcarecollaborator
- Yung Shin Pharm. Ind. Co., Ltd.collaborator
- Zydus Pharmaceuticals USA, Inc.collaborator
Study Sites (1)
Registry Coordinating Center
Wilmington, North Carolina, 28403, United States
Related Publications (2)
Vannappagari V, Albano JD, Koram N, Tilson H, Scheuerle AE, Napier MD. Prenatal exposure to zidovudine and risk for ventricular septal defects and congenital heart defects: data from the Antiretroviral Pregnancy Registry. Eur J Obstet Gynecol Reprod Biol. 2016 Feb;197:6-10. doi: 10.1016/j.ejogrb.2015.11.015. Epub 2015 Nov 24.
PMID: 26687320DERIVEDVannappagari V, Koram N, Albano J, Tilson H, Gee C. Association between in utero zidovudine exposure and nondefect adverse birth outcomes: analysis of prospectively collected data from the Antiretroviral Pregnancy Registry. BJOG. 2016 May;123(6):910-6. doi: 10.1111/1471-0528.13542. Epub 2015 Aug 12.
PMID: 26269220DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica D Albano, PhD, MPH
Syneos Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2006
First Posted
November 29, 2006
Study Start
January 1, 1989
Primary Completion (Estimated)
January 1, 2099
Study Completion (Estimated)
January 1, 2099
Last Updated
April 1, 2025
Record last verified: 2024-06