Difficulties in assigning AIDS endpoints in clinical trials in resource limited settings: Lessons from DART.

DART was designed to compare clinical outcomes under two management strategies in Sub-Saharan Africa. 3316 patients were recruited and followed for up to 6 years accruing 1021 reported WHO 4 events (excluding deaths) to December 2008. The protocol included definitive and presumptive criteria defining each WHO 4 endpoint. Where specific diagnoses could not be allocated to reported events, an independent endpoint review committee developed a “syndromic” categorisation scheme, including “brain syndrome” and "lung syndrome". Syndromes were classified as severe (severity comparable to WHO 4 events) or mild. We compared the rates of rejection of disease endpoints in DART and the last large pre-HAART RCT (DELTA ), completed 12 years previously.