What is the Registry?
The Antiretroviral Pregnancy Registry is intended to provide an early signal of any major teratogenic effect associated with a prenatal exposure to the products monitored through the Registry. The Registry is a voluntary prospective, exposure-registration, observational study designed to collect and evaluate data on the outcomes of pregnancy exposures to antiretroviral products.
An Advisory Committee was established to review data and establish a consensus regarding results of the data at that time and makes recommendations on data collected and on issues arising during the conduct of the Registry. The Committee also encourages referral of reports to the Registry and disseminates Registry information. The Advisory Committee with representatives from the Sponsor companies comprise the Registry Steering Committee. The Steering Committee meets semi-annually to discuss issues, review data, update the interim report published following each meeting, and to discuss the general conduct of the Registry.
Assuring patient confidentiality is a very high priority for the Registry, for this reason no patient identifiers are collected. The Registry has sought and obtained IRB (institutional review board) approval. With the IRB approval of the protocol, the Registry was granted a waiver from obtaining patient informed consent. Additionally, the Registry reviews data privacy issues related to Registry processes on a regular basis.
Because the Registry is very careful to protect the patient's confidentiality participation in the Registry is conducted through a health care provider rather than directly with the patient. The Registry does not collect or maintain patient identifiers such as name, initials, contact information, or date of birth to assure confidentiality. If you would like to know more about the Registry, please ask your health care provider to contact us.
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Why is the Registry Important?
This Registry is the only project expressly established to evaluate first trimester, as well as later prenatal exposures to antiretroviral medications. Registry data supplement other sources of data and assist clinicians and patients in weighing potential risks and benefits of treatment.
There are completed and ongoing clinical trials of several antiretrovirals in pregnant women. However, the manufacturers of these antiretroviral products recognize the need to continuously monitor the safety of their products, particularly for rare events that are difficult to identify in small populations.
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