Antiretroviral Pregnancy Registry

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City:		Wilmington
State:		North Carolina
Zip Code:		28405

Conditions:		HIV Infections - Hepatitis B Virus
Purpose:		The purpose of the Antiretroviral Pregnancy Registry (Registry) is to detect any major teratogenic effect involving any of the Registry drugs when administered to pregnant women. Registration is voluntary and confidential with information obtained from the health care provider. A Registry-assigned identifier allows for follow-up capability. Information on subjects is provided to the Registry prospectively (prior to the outcome of pregnancy being known) through their health care provider, with follow-up obtained from the health care provider after the outcome is determined. Providers are strongly urged to enroll their patients as early in pregnancy as possible to maximize the validity of the data. In addition, the Registry is very interested in assembling a group of providers who are willing to make a commitment to report all of their site's antiretroviral pregnancy exposures to the Registry, thereby assuring all cases can be considered prospective. Providers are encouraged to contact the Registry for more information about this group. The Registry is informed in its analysis by other data, for example, retrospective reports and clinical studies. Given the increasing number of medications and more aggressive approach to therapy, more HIV-infected women may be treated during pregnancy or become pregnant while under treatment. The paucity of data on use and infant outcomes of antiretroviral therapies during pregnancy makes this Registry an essential component of the ongoing program of epidemiologic studies of the safety of these therapies. Each year the Registry enrolls approximately 1300 pregnant women exposed to antiretroviral drugs. This number represents approximately 15% of the 8,700 HIV positive women who give birth to live infants annually in the US.
Study Summary:		The following antiretroviral drugs are followed by the Antiretroviral Pregnancy Registry (APR: Registry) to detect any major teratogenic effect when administered to pregnant women: abacavir (ZIAGEN®, ABC), abacavir/lamivudine (EPZICOM®, EPZ), abacavir/lamivudine/zidovudine combination (TRIZIVIR®, TZV), adefovir dipivoxil (HEPSERA®, ADV), amprenavir (AGENERASE®, APV), atazanavir sulfate (REYATAZ®, ATV), darunavir (PREZISTA®, DRV), delavirdine mesylate (RESCRIPTOR®, DLV), didanosine (VIDEX®, VIDEX® EC, ddI), efavirenz (SUSTIVA®, STOCRIN®, EFV), efavirenz/emtricitabine/tenofovir disoproxil fumarate combination (ATRIPLA, ATR®), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STRIBILD™, STB), emtricitabine (EMTRIVA®, FTC), enfuvirtide (FUZEON®, T-20), entecavir (BARACLUDE®, ETV), etravirine (INTELENCE®, ETR), fosamprenavir calcium (LEXIVA®, FOS), indinavir (CRIXIVAN®, IDV), lamivudine (EPIVIR®, 3TC), lamivudine/zidovudine combination (COMBIVIR®, ZDV+3TC), lopinavir/ritonavir combination (KALETRA®, ALUVIA®, LPV/r), maraviroc (SELZENTRY®, CENSENTRI®, MVC), nelfinavir (VIRACEPT®, NFV), nevirapine (VIRAMUNE®, VIRAMUNE® XR™, NVP), raltegravir (ISENTRESS®, RAL), rilpivirine (EDURANT®, RPV), rilpivirine/emtricitabine/tenofovir disoproxil fumarate combination (COMPLERA®, CPA; EVIPLERA®, EPA), ritonavir (NORVIR®, RTV), saquinavir (FORTOVASE®, SQV-SGC), saquinavir mesylate (INVIRASE®, SQV-HGC), stavudine (ZERIT®, d4T), telbivudine (SEBIVO®, TYZEKA®, LdT), tenofovir disoproxil fumarate (VIREAD®, TDF), tenofovir disoproxil fumarate/emtricitabine combination (TRUVADA®, TVD), tipranavir, (APTIVUS®, TPV), zalcitabine (HIVID®, ddC), and zidovudine (RETROVIR®, ZDV). Zidovudine is indicated for use in the second and third trimesters of pregnancy to reduce the risk of maternal-fetal HIV transmission. There are also several other completed and ongoing studies in maternal-fetal transmission with other therapies. However, the safety of prenatal zidovudine or any other antiretroviral therapy exposure to the fetus has not been established.
Criteria:		Eligibility Ages Eligible for Study: Women of childbearing age Inclusion Criteria: - Country of origin of report - Documentation that the registry drug was taken during pregnancy - Sufficient information to determine if the pregnancy is being prospectively or retrospectively registered - Date the pregnancy was registered - Source of report (patient or health care provider) - Whether the pregnancy outcome is already known or delivery is still pending - Timing of the prenatal exposure to the registry medication (no broader than which trimester) - Sufficient patient identifier relevant to reporter to allow for follow-up - Was patient involved in a study at the time of prenatal exposure - Full reporter contact information (name, address, etc.) Exclusion Criteria: - Females who were not exposed to registry medications during pregnancy - Male patients
NCT ID:		NCT00404989
Primary Contact:		Principal Investigator Jessica D Albano, PhD, MPH INC Research, LLC Cathy Ryan Phone: 800-258-4263 Email: pregnancyregistries@incresearch.com
Backup Contact:		Email: pregnancyregistries@incresearch.com Steffanie Saunders Phone: 800-258-4263
Location Contact:		Wilmington, North Carolina 28405 United States *There is no listed contact information for this specific location.* Site Status: Recruiting

Data Source:		ClinicalTrials.gov
Date Processed:		May 24, 2013
Modifications to this listing:		Only selected fields are shown, please use the link below to view all information about this clinical trial.
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