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Status
Completed
Phase
IV
Principal Investigator(s)
James D Neaton, PhD University of Minnesota - Clinical and Translational Science Institute
Objective
This study seeks to discover if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their cluster-of-differentiation-4 (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines. The START study also wants to learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.
Prevention Option(s)
Treatment
Study Design
Controlled
Randomized
Arms and Assigned Interventions
Description
Initiate ART immediately following randomization.
Mode of Delivery
Tablet
ARMs
Experimental
Description
Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops.
Mode of Delivery
Tablet
ARMs
Placebo Comparator
Official Code
Related Publications
Trial Sponsors
University of Minnesota - Clinical and Translational Science Institute
March 2009
July 2015
Enrollment
4 688
18
Years
Population
Women
Men
HIV positive
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