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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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by INC Research
Sponsor:
Collaborators:
AbbVie
Apotex Inc.
Aurobindo
Boehringer Ingelheim
Bristol-Myers Squibb
Cipla Ltd.
Gilead Sciences
HEC Pharm
Hetero USA
IPCA Laboratories Ltd.
Janssen R&D Ireland
Merck Sharp & Dohme Corp.
Mylan Laboratories
Novartis
Pfizer
Prinston Pharma
Ranbaxy Inc.
Roche Pharma AG
Sciegen Pharmaceuticals
Sigmapharm Laboratories
Strides Arcolab Ltd.
Teva Pharmaceuticals USA
ViiV Healthcare (represented by GlaxoSmithKline)
Information provided by (Responsible Party):
INC Research
ClinicalTrials.gov Identifier:
NCT00404989
First received: November 27, 2006
Last updated: September 19, 2013
Last verified: September 2013
  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.


Condition Phase
HIV Infections
Hepatitis B Virus
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antiretroviral Pregnancy Registry

Resource links provided by NLM:


Further study details as provided by INC Research:

Study Start Date: January 1989
Estimated Study Completion Date: January 2015
Detailed Description:

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), dolutegravir (TIVICAY®), 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.

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pregnant women exposed to antiviral medications during pregnancy.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404989

Contacts
Contact: Susan Goodlow 800-258-4263 SM_APR@INCResearch.com
Contact: Pam Meador 800-258-4263 SM_APR@INCResearch.com

Locations
United States, North Carolina
Registry Coordinating Center Recruiting
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
INC Research
AbbVie
Apotex Inc.
Aurobindo
Boehringer Ingelheim
Bristol-Myers Squibb
Cipla Ltd.
Gilead Sciences
HEC Pharm
Hetero USA
IPCA Laboratories Ltd.
Janssen R&D Ireland
Merck Sharp & Dohme Corp.
Mylan Laboratories
Novartis
Pfizer
Prinston Pharma
Ranbaxy Inc.
Roche Pharma AG
Sciegen Pharmaceuticals
Sigmapharm Laboratories
Strides Arcolab Ltd.
Teva Pharmaceuticals USA
ViiV Healthcare (represented by GlaxoSmithKline)
Investigators
Principal Investigator: Jessica D Albano, PhD, MPH INC Research
  More Information

Additional Information:
No publications provided

Responsible Party: INC Research
ClinicalTrials.gov Identifier: NCT00404989     History of Changes
Other Study ID Numbers: APR
Study First Received: November 27, 2006
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by INC Research:
HIV
HBV
Hepatitis
Pregnancy
Registry

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis B
DNA Virus Infections
Digestive System Diseases
Hepadnaviridae Infections
Hepatitis, Viral, Human
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014