Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2010 Jul-Aug;11(4):205-19.
doi: 10.1310/hct1104-205.

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

Alan R Lifson  1 ; INSIGHT Endpoint Review Committee Writing Group; Waldo H Belloso, Richard T Davey, Daniel Duprez, Jose M Gatell, Jennifer F Hoy, Eric A Krum, Ray Nelson, Court Pedersen, George Perez, Richard W Price, Ronald J Prineas, Frank S Rhame, James H Sampson, John Worley, INSIGHT Study Group
Collaborators, Affiliations

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

Alan R Lifson et al. HIV Clin Trials. 2010 Jul-Aug.

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.

PubMed Disclaimer

Figures

Figure A1
Figure A1
Sample case report form
Figure A1
Figure A1
Sample case report form
Figure A1
Figure A1
Sample case report form
See this image and copyright information in PMC

References

    1. Palella FJ, Baker RK, Moorman AC, et al. Mortality in the highly active antiretroviral therapy era: changing causes of death and disease in the HIV outpatient study. J Acquir Immune Defic Syndr. 2006;43:27–34. - PubMed
    1. Phillips AN, Neaton J, Lundgren JD. The role of HIV in serious diseases other than AIDS. AIDS. 2008;22:2409–2418. - PMC - PubMed
    1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Department of Health and Human Services. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. 2009 December 1;:1–161 . http://www.aidsinfo.nih.gov/ContentFiles/Adultand-AdolescentGL.pdf.
    1. Thompson MA, Aberg JA, Cahn P, et al. Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society--USA Panel. JAMA. 2010;304:321–333. - PubMed
    1. Lau B, Gange SJ, Moore RD. Risk of non-AIDS-related mortality may exceed risk of AIDS-related mortality among individuals enrolling into care with CD4+ counts greater than 200 cells/mm3. J Acquir Immune Defic Syndr. 2007;44:179–187. - PubMed

Publication types

MeSH terms