Antiretroviral Pregnancy Registry (APR)-Risk of Birth Defects
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/26/2017 |
| Start Date: | February 15, 1993 |
| End Date: | December 31, 2024 |
| Contact: | US GSK Clinical Trials Call Center |
| Email: | GSKClinicalSupportHD@gsk.com |
| Phone: | 877-379-3718 |
Antiretroviral Pregnancy Registry (APR)-Risk of Birth Defects Associated With Exposure to GSK HIV Drugs During Pregnancy
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.
'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.
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.
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.
Inclusion Criteria:
- Any pregnant, HIV positive woman exposed to antiretroviral drugs during pregnancy.
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