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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 : April 22, 2022
Sponsor:
Collaborators:
AbbVie
Accord Healthcare, Inc.
Alvogen Korea
Amneal Pharmaceuticals, LLC
Apotex Inc.
Aurobindo Pharma Ltd
Boehringer Ingelheim
Bristol-Myers Squibb
Celltrion
Cipla Ltd.
Gilead Sciences
Hetero Labs
Hikma Pharmaceuticals LLC
Janssen Scientific Affairs, LLC
Lannett Company, Inc.
Lupin Pharmaceuticals, Inc.
Macleods Pharmaceuticals, Ltd
Merck Sharp & Dohme LLC
Mylan Laboratories
Prinston Pharmaceutical Inc.
Qilu Pharmaceutical Co., Ltd.
Sigmapharm Laboratories
Strides Shasun Limited
Teva Pharmaceuticals USA
ViiV Healthcare
Pharmascience Inc.
Sandoz Canada Inc.
Laurus Labs Limited
Information provided by (Responsible Party):
Syneos Health

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 1300-1700 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

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®, KIVEXA®, EPZ), abacavir/lamivudine/zidovudine (TRIZIVIR®, TZV), abacavir/dolutegravir/lamivudine (TRIUMEQ®, TRI), adefovir dipivoxil (HEPSERA®, ADV), amprenavir (AGENERASE®, APV), atazanavir (REYATAZ®, ATV), atazanavir/cobicistat (EVOTAZ®, EVO), bictegravir/emtricitabine/tenofovir alafenamide (BIKTARVY®, B/F/TAF), cabotegravir (VOCABRIA®, CABENUVA®, APRETUDE®, CAB), cobicistat (TYBOST®, COBI), darunavir (PREZISTA®, DRV), darunavir/cobicistat (PREZCOBIX™, REZOLSTA™, PCX), darunavir/cobicistat/emtricitabine/tenofovir alafenamide (SYMTUZA®, DCF TAF ), delavirdine mesylate (RESCRIPTOR®, DLV), didanosine (VIDEX®, VIDEX® EC, ddI), dolutegravir (TIVICAY®, DTG), dolutegravir/lamivudine (DOVATO®, DTG/RPV), dolutegravir/lamivudine/tenofovir disoproxil fumarate (ACRIPTEGA/TELADOMYL/TENDOLA, TLD), dolutegravir/rilpivirine (JULUCA™, DTG/RPV), emtricitabine/tenofovir alafenamide (DESCOVY®, DVY), efavirenz (SUSTIVA®, STOCRIN®, EFV), efavirenz/emtricitabine/tenofovir disoproxil (ATRIPLA® ATR), efavirenz/lamivudine/tenofovir disoproxil fumarate (SYMFI™/SYMFI LO™, EFV/3TC/TDF), elvitegravir (VITEKTA®, EVG), elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (GENVOYA®, GEN), 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), fostemsavir (RUKOBIA, FTR), indinavir (CRIXIVAN®, IDV), lamivudine (EPIVIR®, 3TC), lamivudine/raltegravir (DUTREBIS™, DUT), lamivudine/tenofovir disoproxil fumarate (CIMDUO™, 3TC/TDF), lamivudine/zidovudine (COMBIVIR®, CBV), lopinavir/ritonavir (KALETRA®, ALUVIA®, LPV/r), maraviroc (SELZENTRY®, CELSENTRI®, MVC), nelfinavir (VIRACEPT®, NFV), nevirapine (VIRAMUNE®, VIRAMUNE® XR™, NVP), raltegravir (ISENTRESS®, RAL), rilpivirine (EDURANT®, REKAMBYS®, CABENUVA®, RPV), rilpivirine/emtricitabine/tenofovir alafenamide (ODEFSEY®,ODE), rilpivirine/emtricitabine/tenofovir disoproxil (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).

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Study Type : Observational
Estimated Enrollment : 24258 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 Pregnancy





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:   No
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

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


Contacts
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Contact: Taylor Cook 800-258-4263 SM_APR@APRegistry.com

Locations
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United States, North Carolina
Registry Coordinating Center Recruiting
Wilmington, North Carolina, United States, 28403
Sponsors and Collaborators
Syneos Health
AbbVie
Accord Healthcare, Inc.
Alvogen Korea
Amneal Pharmaceuticals, LLC
Apotex Inc.
Aurobindo Pharma Ltd
Boehringer Ingelheim
Bristol-Myers Squibb
Celltrion
Cipla Ltd.
Gilead Sciences
Hetero Labs
Hikma Pharmaceuticals LLC
Janssen Scientific Affairs, LLC
Lannett Company, Inc.
Lupin Pharmaceuticals, Inc.
Macleods Pharmaceuticals, Ltd
Merck Sharp & Dohme LLC
Mylan Laboratories
Prinston Pharmaceutical Inc.
Qilu Pharmaceutical Co., Ltd.
Sigmapharm Laboratories
Strides Shasun Limited
Teva Pharmaceuticals USA
ViiV Healthcare
Pharmascience Inc.
Sandoz Canada Inc.
Laurus Labs Limited
Investigators
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Principal Investigator: Jessica D Albano, PhD, MPH Syneos Health
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Syneos Health
ClinicalTrials.gov Identifier: NCT00404989    
Obsolete Identifiers: NCT01137981
Other Study ID Numbers: APR
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Keywords provided by Syneos Health:
HIV
HBV
Hepatitis
Pregnancy
Registry
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections