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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. (APR)

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ClinicalTrials.gov Identifier: NCT00404989
Recruitment Status : Recruiting
First Posted : November 29, 2006
Last Update Posted : July 6, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 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

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 combination (EPZICOM®, 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), cobicistat (TYBOST®, COBI), darunavir (PREZISTA®, DRV), darunavir/cobicistat combination (PREZCOBIX™, REZOLSTA™, PCX), delavirdine mesylate (RESCRIPTOR®, DLV), didanosine (VIDEX®, VIDEX® EC, ddI), dolutegravir (TIVICAY®, DTG), emtricitabine/ tenofovir alafenamide (DESCOVY®,DVY) efavirenz (SUSTIVA®, STOCRIN®, EFV), efavirenz/emtricitabine/ tenofovir disoproxil combination (ATRIPLA® ATR), 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/zidovudine combination (COMBIVIR®, ZDV+3TC), 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 (GENVOYA®,GEN) 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 Design

Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antiretroviral Pregnancy Registry
Study Start Date : January 1989
Estimated Primary Completion Date : January 2099
Estimated Study Completion Date : January 2099

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women exposed to antiviral medications during pregnancy.

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

Information from the National Library of Medicine

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: 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
Sponsors and Collaborators
INC Research
Apotex Inc.
Aurobindo Pharma
Boehringer Ingelheim
Bristol-Myers Squibb
Cipla Ltd.
Hoffmann-La Roche
Gilead Sciences
Hetero Labs Ltd.
Janssen Scientific Affairs
Lupin Pharmaceuticals, Inc.
Merck Sharp & Dohme Corp.
Mylan Laboratories
Novartis Pharmaceuticals
Prinston Pharmaceutical Inc.
Ranbaxy Inc., a SunPharma Co.
Sciegen Pharmaceuticals Inc.
Sigmapharm Laboratories
Silarx Pharmaceuticals Inc
Strides Shasun Ltd.
Teva Pharmaceuticals USA
ViiV Healthcare
Alvogen Korea
Amneal Pharmaceuticals, LLC
West-Ward Pharmaceutical
Dr. Reddy's Laboratories UK Ltd.
Zentiva Group
Principal Investigator: Jessica D Albano, PhD, MPH INC Research
More Information

Additional Information:
Responsible Party: INC Research
ClinicalTrials.gov Identifier: NCT00404989     History of Changes
Other Study ID Numbers: APR
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

Keywords provided by INC Research:

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