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New Clinical Alert Issued by National Institute of Allergy and Infectious Diseases (NIAID)

January 19, 2006 [posted]

The National Institute of Allergy and Infectious Diseases (NIAID), issued a new Clinical Alert on January 18, 2006:

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced that enrollment into a large international HIV/AIDS trial comparing continuous antiretroviral therapy with episodic drug treatment guided by levels of CD4+ cells has been stopped. Enrollment was stopped because those patients receiving episodic therapy had twice the risk of disease progression (the development of clinical AIDS or death), the major outcome of the study.

NIAID made the decision to halt enrollment in collaboration with the study's Executive Committee and following a recommendation received from an independent Data and Safety Monitoring Board (DSMB). The DSMB, charged with regularly evaluating data and safety issues during the multi-year trial, conducted a review of the interim study data in early January.

Links to Clinical Alerts/Advisories can also be found from these NLM Web sites:

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