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| Sponsors and Collaborators: |
Kendle International Abbott Aurobindo Barr Laboratories Boehringer Ingelheim Pharmaceuticals Bristol-Myers Squibb Cipla Gilead Sciences GlaxoSmithKline Hoffmann-La Roche Merck Mylan Laboratories Novartis Pfizer Ranbaxy Inc. Tibotec Pharmaceutical Limited |
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| Information provided by: | Kendle International |
| ClinicalTrials.gov Identifier: | NCT00404989 |
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 1000 pregnant women exposed to antiretroviral drugs. This number represents approximately 15% of the 6000-7000 HIV positive women who give birth to live infants annually in the US.
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Antiretroviral Pregnancy Registry |
| Study Start Date: | January 1989 |
| Estimated Study Completion Date: | June 2010 |
The following antiretroviral drugs are followed by the Antiretroviral Pregnancy Registry (Registry) to detect any major teratogenic effect when administered to pregnant women: abacavir (ZIAGEN®, ABC), abacavir/lamivudine (EPZICOM®), 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), efavirenz (SUSTIVA®, STOCRIN®, EFV), efavirenz/ emtricitabine/tenofovir disoproxil fumarate combination (ATRIPLA, ATR™), 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®, NVP), raltegravir (ISENTRESS™, RAL), 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 |
Pregnant women exposed to antiviral medications during pregnancy.
Eligibility Ages Eligible for Study: Women of childbearing age
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kim T Freeman, BA | 800-258-4263 | apr@kendle.com |
| Contact: Kathryn A Page | 800-258-4263 | apr@kendle.com |
| United States, North Carolina | |
| Registry Coordinating Center | Recruiting |
| Wilmington, North Carolina, United States, 28405 | |
| Principal Investigator: | Deborah L Covington, DrPH | Kendle International Inc. |
More Information
| Responsible Party: | Kendle ( Kim Freeman ) |
| Study ID Numbers: | APR |
| Study First Received: | November 27, 2006 |
| Last Updated: | May 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00404989 |
| Health Authority: | United States: Institutional Review Board |
|
HIV HBV Hepatitis Pregnancy Registry |
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Sexually Transmitted Diseases, Viral Liver Diseases Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Immunologic Deficiency Syndromes Hepatitis Virus Diseases |
Digestive System Diseases HIV Infections Sexually Transmitted Diseases Hepatitis B DNA Virus Infections Retroviridae Infections |
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RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Lentivirus Infections Infection Hepadnaviridae Infections |
