The START study opened to recruitment in April 2009 and is being conducted in 22 countries worldwide. The aim of the study is to evaluate if starting HIV medicines earlier – before CD4 cells drop to below 500 cells/mm3 - will reduce the risk of developing serious non-AIDS illnesses as well as reduce the risk of the traditional AIDS illnesses.
On 1st December 2009 the United States Department of Health and Human Services released new guidelines for the use of antiretroviral therapy for the treatment of HIV.
The new guidelines recommend initiation of ART in individuals with CD4 cell counts between 350 and 500 cells/mm3, although the extent of support within the panel for this recommendation remains unclear. In addition, the guidelines indicate that commencement of antiretroviral therapy in a person with more than 500 CD4 cells/mm3 should be regarded as optional – a recommendation that the guidelines acknowledge with even less evidence.
Guidelines in most other regions of the world continue to recommend initiation of therapy in asymptomatic HIV-positive persons when CD4 cell counts reach 350 cells/mm3.
The START protocol team have reviewed the new US guidelines and the data on which the new guidelines are based, and their position is that clinical uncertainty remains substantial regarding whether ART should be started when the CD4 count is greater than 500 cells/mm3 or deferred until the CD4 count nears 350 cells/mm3. This view was also endorsed by START site principal investigators.
The START protocol team have confirmed the design of the study will not change, and investigators will be provided information to share with participants and ethics committees regarding the revised US guidelines.
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