Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant Women. (APR)
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|ClinicalTrials.gov Identifier: NCT00404989|
Recruitment Status : Recruiting
First Posted : November 29, 2006
Last Update Posted : April 5, 2019
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- and hepatitis B-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 has enrolled approximately 1300-1700 pregnant women in the US 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.
|Condition or disease|
|HIV Infections Hepatitis B|
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 combination (EPZICOM®, KIVEXA®, EPZ), abacavir/lamivudine/zidovudine combination (TRIZIVIR®, TZV), abacavir/dolutegravir/lamivudine combination (TRIUMEQ®, TRI), adefovir dipivoxil (HEPSERA®, ADV), amprenavir (AGENERASE®, APV), atazanavir (REYATAZ®, ATV), atazanavir/cobicistat combination (EVOTAZ®, EVO), bictegravir/emtriciabine/tenofovir alafenamide (BIKTARVY®, B/F/TAF), cobicistat (TYBOST®, COBI), darunavir (PREZISTA®, DRV), darunavir/cobicistat combination (PREZCOBIX™, REZOLSTA™, PCX), delavirdine mesylate (RESCRIPTOR®, DLV), didanosine (VIDEX®, VIDEX® EC, ddI), dolutegravir (TIVICAY®, DTG), dolutegravir+lamivudine+tenofovir disoproxil fumarate (acriptega/teladomyl/tendola, TLD), dolutegravir/rilpivirine (JULUCA™, DTG/RPV), doravirine (pifeltro™, PIF), doravirine+lamivudine+tenofovir disoproxil fumarate (delstrigo™, DEL), emtricitabine/ tenofovir alafenamide (DESCOVY®,DVY) efavirenz (SUSTIVA®, STOCRIN®, EFV), efavirenz/emtricitabine/ tenofovir disoproxil combination (ATRIPLA® ATR), efavirenz/lamivudine/tenofovir disoproxil fumarate (SYMFI LO™, EFV/3TC/TDF), elvitegravir (VITEKTA®, EVG), elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide combination (GENVOYA®, GEN), 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/raltegravir combination (DUTREBIS™, DUT), lamivudine/tenofovir disoproxil fumarate (CIMDUO™, 3TC/TDF), lamivudine/zidovudine combination (COMBIVIR®, CBV), lopinavir/ritonavir combination (KALETRA®, ALUVIA®, LPV/r), maraviroc (SELZENTRY®, CELSENTRI®, MVC), nelfinavir (VIRACEPT®, NFV), nevirapine (VIRAMUNE®, VIRAMUNE® XR™, NVP), raltegravir (ISENTRESS®, RAL), rilpivirine (EDURANT®, RPV), rilpivirine/emtricitabine/tenofovir alafenamide (ODEFSEY®,ODE) rilpivirine/emtricitabine/tenofovir disoproxil 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 alafenamide (VEMLIDY®, TAF), tenofovir disoproxil fumarate (VIREAD®, TDF), tenofovir disoproxil fumarate /emtricitabine (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.
|Study Type :||Observational|
|Estimated Enrollment :||1600 participants|
|Official Title:||Antiretroviral Pregnancy Registry|
|Study Start Date :||January 1989|
|Estimated Primary Completion Date :||January 2099|
|Estimated Study Completion Date :||January 2099|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404989
|Contact: Taylor Cook||800-258-4263||SM_APR@syneoshealth.com|
|United States, North Carolina|
|Registry Coordinating Center||Recruiting|
|Wilmington, North Carolina, United States, 28403|
|Principal Investigator:||Jessica D Albano, PhD, MPH||Syneos Health|