Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials.
OBJECTIVE
Serious non-AIDS (SNA) diseases are important causes of morbidity and mortality in the HAART era. We describe development of standard criteria for 12 SNA events for Endpoint Review Committee (ERC) use in START, a multicenter international HIV clinical trial.


METHODS
SNA definitions were developed based upon the following: (1) criteria from a previous trial (SMART), (2) review of published literature, (3) an iterative consultation and review process with the ERC and other content experts, and (4) evaluation of draft SNA criteria using retrospectively collected reports in another trial (ESPRIT).


RESULTS
Final criteria are presented for acute myocardial infarction, congestive heart failure, coronary artery disease requiring drug treatment, coronary revascularization, decompensated liver disease, deep vein thrombosis, diabetes mellitus, end-stage renal disease, non-AIDS cancer, peripheral arterial disease, pulmonary embolism, and stroke. Of 563 potential SNA events reported in ESPRIT and reviewed by an ERC, 72% met "confirmed" and 13% "probable" criteria. Twenty-eight percent of cases initially reviewed by the ERC required follow-up discussion (adjudication) before a final decision was reached.


CONCLUSIONS
HIV clinical trials that include SNA diseases as clinical outcomes should have standardized SNA definitions to optimize event reporting and validation and should have review by an experienced ERC with opportunities for adjudication.
Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota 55454-1015, USA. lifso001@umn.edu
Alan R
AR
Lifson
Waldo H
WH
Belloso
Richard T
RT
Davey
Daniel
D
Duprez
Jose M
JM
Gatell
Jennifer F
JF
Hoy
Eric A
EA
Krum
Ray
R
Nelson
Court
C
Pedersen
George
G
Perez
Richard W
RW
Price
Ronald J
RJ
Prineas
Frank S
FS
Rhame
James H
JH
Sampson
John
J
Worley
INSIGHT Study Group
D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000821:virology*; D019937:Diagnostic Techniques and Procedures; D023381:Endpoint Determination; D006678:HIV / Q000254:growth & development*; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy; D006801:Humans; D007674:Kidney Diseases / Q000175:diagnosis / Q000821:virology*; D008107:Liver Diseases / Q000175:diagnosis / Q000821:virology*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012189:Retrospective Studies