Antiretroviral Pregnancy Registry (APR)-Risk of Birth Defects

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by ViiV Healthcare
INC Research
Information provided by (Responsible Party):
ViiV Healthcare Identifier:
First received: March 25, 2010
Last updated: February 18, 2016
Last verified: February 2016

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.

Condition Intervention
Infection, Human Immunodeficiency Virus
Drug: Any Antiretroviral Therapy

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 31 Years
Official Title: Antiretroviral Pregnancy Registry (APR)-Risk of Birth Defects Associated With Exposure to GSK HIV Drugs During Pregnancy

Resource links provided by NLM:

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • A birth defect is defined as any congenital malformations according to modified (by APR) classification of Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP) criteria [ Time Frame: Birth defect is to be diagnosed in fetuses of at least 20 weeks gestational age through children of up to 6 years of age ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1
Study Start Date: February 1993
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant, HIV Positive Women
Any pregnant, HIV positive woman exposed to antiretroviral drugs during pregnancy.
Drug: Any Antiretroviral Therapy
Any exposure to an antiretroviral therapy: Abacavir, Amprenavir, Delavirdine, Fosamprenavir, Lamivudine, Maraviroc, Zidovudine, Combivir (Zidovudine+Lamivudine), Epzicom (Abacavir+Lamivudine), and/or Trizivir (Abacavir+Lamivudine+Zidovudine)

Detailed Description:

The Registry conforms to the FDA Guidance for Industry: Establishing Pregnancy Exposure Registries, the Guidelines for Good Pharmacoepidemiology Practices, and the FDA Guidance on Pharmacovigilance.

The Antiretroviral Pregnancy Registry collects data on use of the following GSK drugs: abacavir, amprenavir, delavirdine, fosamprenavir, lamivudine, maraviroc, zidovudine, and their combinations during pregnancy. The Registry requests information from medical providers about antiretroviral therapy, though there may be other drug exposures, which are not systematically collected.

Registration is voluntary. Health professionals are strongly encouraged to enroll their antiretroviral-exposed pregnant patients into the Registry as early in the pregnancy as possible, preferably before prenatal testing is done. This is to maximize the data validity by minimizing potential biases introduced when a woman is enrolled after prenatal testing.

Patients are followed through health care providers who provide information on maternal risk factors, pregnancy outcome, and neonatal health. In the month of expected delivery, a short follow-up form is sent to the health care provider to ascertain the pregnancy outcome and completion of the antiviral therapy information. Additional follow-up is not sought from health care providers.

In an attempt to limit the bias in the analysis, the Registry assembled a group of providers who committed in writing to report every woman who receives antiretroviral therapy during pregnancy, but before the pregnancy outcome is known, that comes to their site. This allows the Registry to include every report from that site as an evaluable case. As the number of cases from these sites increases, the Registry will be able to analyze those cases separately. Providers are encouraged to participate in this group.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any pregnant, HIV positive woman exposed to antiretroviral drugs during pregnancy is eligible to enroll. Registration is voluntary. Health professionals are strongly encouraged to enroll their antiretroviral-exposed pregnant patients into the Registry as early in the pregnancy as possible, preferably before prenatal testing is done.

Inclusion Criteria:

  • Any pregnant, HIV positive woman exposed to antiretroviral drugs during pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01137981

Contact: US GSK Clinical Trials Call Center 877-379-3718

United States, North Carolina
GSK Investigational Site Recruiting
Wilmington, North Carolina, United States, 28405
Contact: US Clincal Trials Call Center    877-379-3718   
Contact: EU Clinical Trials Call Center    +44 (0) 20 8990 4466   
Sponsors and Collaborators
ViiV Healthcare
INC Research
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

Additional Information:
The Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy registry International Interim report for 1 January 1989 through 31 January 2010. Wilmington, NC: Registry Coordinating Center; 2010. Available from URL:

Responsible Party: ViiV Healthcare Identifier: NCT01137981     History of Changes
Other Study ID Numbers: 112885  WE066 (EPIP095)  EPI40018  APR 
Study First Received: March 25, 2010
Last Updated: February 18, 2016
Health Authority: United States: No Health Authority

Keywords provided by ViiV Healthcare:
Combivir (Zidovudine+Lamivudine)
Antiretroviral Pregnancy Registry
pregnancy registry
Trizivir (Abacavir+Lamivudine+Zidovudine)
Epzicom (Abacavir+Lamivudine)

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Lamivudine, zidovudine drug combination
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors processed this record on May 25, 2016