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NCT00404989 · ClinicalTrials.gov registry record
Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant People.
A clinical trial of HIV Infections and Hepatitis B, sponsored by Syneos Health.
- Recruiting
- Registry status
- 24,258
- Enrollment target
- 1
- Study location
NCT00404989 is a study of HIV Infections and Hepatitis B that is actively recruiting participants, run by Syneos Health. The registered enrollment target is 24,258 participants, above the 401-participant average among 542 other HIV Infections trials with a reported enrollment target (5949% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00404989, a study of HIV Infections and Hepatitis B, is actively recruiting participants, sponsored by Syneos Health.
- RECRUITING
- Registry status
- 24,258 participants
- Enrollment target
- 1
- Study location
Study 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 people. 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 people 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 people in the US exposed to antiretroviral drugs. This number represents approximately 15% of the 8,700 HIV positive people who give birth to live infants annually in the US.
Conditions Studied
Study Locations (1)
North Carolina
- Registry Coordinating Center - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24,258 participants |
| Start Date | 1989-01 |
| Est. Completion | 2099-01 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00404989
The ClinicalTrials.gov registry entry for NCT00404989 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 24,258 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 401-participant average among 542 other HIV Infections trials with a reported enrollment target (5949% higher). The listed sponsor is Syneos Health, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 0 interventions.
NCT00404989 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00404989 about?
NCT00404989 is a clinical study titled "Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant People.". 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 people. Registration is voluntary and confidential with information obtained from the health care provider. A Registry-assigned ...
What is the current status of trial NCT00404989?
This trial is currently recruiting. The enrollment target is 24,258 participants. The study started on 1989-01. Estimated completion is 2099-01.
What conditions does trial NCT00404989 study?
This clinical trial studies the following conditions: HIV Infections, Hepatitis B.
Who is sponsoring clinical trial NCT00404989?
This trial is sponsored by Syneos Health, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00404989 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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