Optimizing Clinical Trial Design to Maximize Evidence Generation in Pediatric HIV.

20 The trial continued over 5 years, and demonstrated sustained benefit of early ART with both experimental arms performing better than deferred ART and a nonsignificant trend toward better outcomes with 96 weeks compared with 40 weeks of ART. 19 The CHAPAS-3 trial in Zambia and Uganda (2010–2014) was another 3-arm trial, powered for a toxicity primary endpoint comparing 3 nucleoside backbones in both ART-naive and virologically suppressed children on stavudine-based first-line ART (Fig. 1 B). 21 Factorial RCT A factorial trial simultaneously allows for 2 (or more) interventions, preferably targeting different aspects of a patient's disease, to be compared with standard treatment(s).

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