Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant Women.

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by INC Research
Sponsor:
Collaborators:
AbbVie
Apotex Inc.
Aurobindo
Boehringer Ingelheim
Bristol-Myers Squibb
Cipla Ltd.
F.Hoffman-La Roche
Gilead Sciences
Hetero
Janssen R&D Ireland
Lupin Pharmaceuticals
Merck Sharp & Dohme Corp.
Mylan Laboratories
Novartis
Pfizer
Prinston
Ranbaxy Inc.
Sandoz Inc.
Sciegen Pharmaceuticals
Sigmapharm Laboratories
Silarx Pharmaceuticals Inc
Strides Arcolab Ltd.
Sunshine Lake Pharma
Teva Pharmaceuticals USA
ViiV Healthcare
Information provided by (Responsible Party):
INC Research
ClinicalTrials.gov Identifier:
NCT00404989
First received: November 27, 2006
Last updated: March 31, 2015
Last verified: March 2015

November 27, 2006
March 31, 2015
January 1989
January 2099   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00404989 on ClinicalTrials.gov Archive Site
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Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant Women.
Antiretroviral Pregnancy Registry

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Pregnant women exposed to antiviral medications during pregnancy.

  • HIV Infections
  • Hepatitis B
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1600
January 2099
January 2099   (final data collection date for primary outcome measure)

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
Female
12 Years to 60 Years
Yes
Contact: Susan Goodlow 800-258-4263 SM_APR@INCResearch.com
Contact: Taylor Cook 800-258-4263 SM_APR@INCResearch.com
United States
 
NCT00404989
APR
Yes
INC Research
INC Research
  • AbbVie
  • Apotex Inc.
  • Aurobindo
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Cipla Ltd.
  • F.Hoffman-La Roche
  • Gilead Sciences
  • Hetero
  • Janssen R&D Ireland
  • Lupin Pharmaceuticals
  • Merck Sharp & Dohme Corp.
  • Mylan Laboratories
  • Novartis
  • Pfizer
  • Prinston
  • Ranbaxy Inc.
  • Sandoz Inc.
  • Sciegen Pharmaceuticals
  • Sigmapharm Laboratories
  • Silarx Pharmaceuticals Inc
  • Strides Arcolab Ltd.
  • Sunshine Lake Pharma
  • Teva Pharmaceuticals USA
  • ViiV Healthcare
Principal Investigator: Jessica D Albano, PhD, MPH INC Research
INC Research
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP