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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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00404989 |
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Recruitment Status :
Recruiting
First Posted : November 29, 2006
Last Update Posted : November 22, 2023
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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 |
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| HIV Infections Hepatitis B |
| 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 |
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years to 60 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
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: Taylor Cook | 800-258-4263 | SM_APR@APRegistry.com |
| United States, North Carolina | |
| Registry Coordinating Center | Recruiting |
| Wilmington, North Carolina, United States, 28403 | |
| Principal Investigator: | Jessica D Albano, PhD, MPH | Syneos Health |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | November 22, 2023 |
| Last Verified: | November 2023 |
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HIV HBV Hepatitis Pregnancy Registry |
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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 |