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START study responds to revised US guidelines for use of ART
START study responds to revised US guidelines for use of
ART
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.
For more information please contact: start@ctu.mrc.ac.uk.
