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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