Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant Women.
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Antiretroviral Pregnancy Registry|
|Study Start Date:||January 1989|
|Estimated Study Completion Date:||January 2099|
|Estimated Primary Completion Date:||January 2099 (Final data collection date for primary outcome measure)|
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), abacavir/dolutegravir/lamivudine combination (TRIUMEQ®, TRI), adefovir dipivoxil (HEPSERA®, ADV)*, amprenavir (AGENERASE®, APV), atazanavir sulfate (REYATAZ®, ATV), atazanavir/cobicistat combination (EVOTAZ®, EVO), cobicistat (TYBOST®, COBI), darunavir (PREZISTA®, DRV), darunavir/cobicistat combination (PREZCOBIX™, PCX), delavirdine mesylate (RESCRIPTOR®, DLV), didanosine (VIDEX®, VIDEX® EC, DDI), dolutegravir (TIVICAY®, DTG), efavirenz (SUSTIVA®, STOCRIN®, EFV), efavirenz/emtricitabine/tenofovir disoproxil fumarate combination (ATRIPLA, ATR®), elvitegravir (VITEKTA®, EVG), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate combination (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404989
|Contact: Susan Goodlow||800-258-4263||SM_APR@INCResearch.com|
|Contact: Taylor Cook||800-258-4263||SM_APR@INCResearch.com|
|United States, North Carolina|
|Registry Coordinating Center||Recruiting|
|Wilmington, North Carolina, United States, 28405|
|Principal Investigator:||Jessica D Albano, PhD, MPH||INC Research|