Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials

Alan Lifson, Waldo Belloso, Richard Davey, Daniel Duprez, Jose Gatell, Jennifer Hoy, Eric Krum, Ray Nelson, Court Pedersen, George Perez, Richard Price, Ronald Prineas, Frank Rhame, James Sampson, John Worley

Research output: Contribution to journalArticlepeer-review

35 Scopus citations

Abstract

Purpose: 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. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)205-219
Number of pages15
JournalHIV Clinical Trials
Volume11
Issue number4
DOIs
StatePublished - Jan 1 2010

Keywords

  • HIV
  • cardiovascular disease
  • clinical trials
  • endpoint review committees
  • serious non-AIDS events

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