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One of the most important medical factors not adequately addressed in any proposed WTST is the individual rate of disease progression.
Many health care providers are concerned about enrolling patients with early HIV disease in a WTST in which they could be randomized to premature, immediate treatment.
There must be a meaningful assessment of the opportunity costs of a large, simple, but expensive WTST. What will the effect of a WTST be on enrollment of treatment-naive subjects in other important studies that try to answer key questions concerning treatment choices?
Perhaps most important is the question of how informed consent will be conducted in a meaningful way in a WTST. At the January 2000 meeting between NIAID and the community, many of the most vocal supporters of a large, simple WTST admitted that they would never allow the timing of their own treatment to be determined by the flip of a coin.
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