Antiretroviral Pregnancy Registry (APR)-Risk of Birth Defects

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by ViiV Healthcare
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01137981
First received: March 25, 2010
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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 Kendle International Inc. 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 16 pharmaceutical companies that manufacture drugs used in ART.


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

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 22 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: January 2015
Estimated Primary Completion Date: January 2015 (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.

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01137981

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

Locations
United States, North Carolina
GSK Investigational Site Recruiting
Wilmington, North Carolina, United States, 28405
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

Additional Information:
No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01137981     History of Changes
Other Study ID Numbers: 112885, WE066 (EPIP095), EPI40018
Study First Received: March 25, 2010
Last Updated: July 31, 2013
Health Authority: United States: No Health Authority

Keywords provided by ViiV Healthcare:
Combivir (Zidovudine+Lamivudine)
Antiretrovirals
ARV
HAART
Maraviroc
Delavirdine
Lamivudine
Antiretroviral Pregnancy Registry
Fosamprenavir
APR
Zidovudine
pregnancy registry
Amprenavir
HIV
Trizivir (Abacavir+Lamivudine+Zidovudine)
Epzicom (Abacavir+Lamivudine)

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

ClinicalTrials.gov processed this record on July 20, 2014