Antiretroviral Pregnancy Registry (APR)-Risk of Birth Defects

HIV Infections Clinical Trial

Official title:

Antiretroviral Pregnancy Registry (APR)-Risk of Birth Defects Associated With Exposure to GSK HIV Drugs During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01137981
• Other study ID #: 112885
• Secondary ID: WE066 (EPIP095)E
• Status: Recruiting
• Start date: February 15, 1993
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2021
• Source: ViiV Healthcare
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any pregnant, HIV positive woman exposed to antiretroviral drugs during pregnancy.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• Congenital Abnormalities
• HIV Infections
• Infection, Human Immunodeficiency Virus
• Infections

Intervention

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)

Locations

Country	Name	City	State
United States	GSK Investigational Site	Wilmington	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline, Syneos Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Vannappagari V, Koram N, Albano J, Tilson H, Gee C. Abacavir and lamivudine exposures during pregnancy and non-defect adverse pregnancy outcomes: data from the antiretroviral pregnancy registry. J Acquir Immune Defic Syndr. 2015 Mar 1;68(3):359-64. doi: 10.1097/QAI.0000000000000465. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Birth defect is to be diagnosed in fetuses of at least 20 weeks gestational age through children of up to 6 years of age