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Antiretroviral Pregnancy Registry (APR)-Risk of Birth Defects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01137981
Recruitment Status : Recruiting
First Posted : June 7, 2010
Last Update Posted : October 24, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Infection, Human Immunodeficiency Virus Drug: Any Antiretroviral Therapy

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.

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1 participants
Observational Model: Other
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
Actual Study Start Date : February 15, 1993
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137981

Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

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
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: www.APRegistry.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01137981     History of Changes
Other Study ID Numbers: 112885
WE066 (EPIP095) ( Other Identifier: GSK )
EPI40018 ( Other Identifier: GSK )
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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