Structured Treatment Interruptions Workshop Summary
January 31, 2001
The number of variables that must be considered when designing trials to evaluate potential immune benefits are daunting: The duration of a scheduled interruption may be determined by:
(CD4+ or RNA triggers can be defined as absolute numbers or as relative changes from a setpoint.)
The choice of number and duration of subsequent interruptions multiplies the variables:
The duration of treatment after interruption is another consideration:
Hypotheses exist to support each of these approaches, and evidence from animal models can be used to argue for one or another. Short of hitting on a lucky combination in another round of small trials, much basic science and animal research may be needed before interruption schedules for large Phase III trials can be confidently selected. Appendix 2
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