The Oral HIV/AIDS Research Alliance: updated case definitions of oral disease endpoints

• Type of Material: Article
• Authors: Caroline H. Shiboski, University of California San Francisco; Lauren L. Patton, University of North Carolina; Jennifer Y. Webster-Cyriaque, University of North Carolina; Deborah Greenspan, University of California San Francisco; Rana S. Traboulsi, Case Western Reserve University; Mahmoud Ghannoum, Case Western Reserve University; Rick Jurevic, Case Western Reserve University; Joan A. Phelan, New York University; David Reznik, Emory University; John S. Greenspan, University of California San Francisco
• Language: English
• Date: 2009-07-01
• Publisher: WILEY-BLACKWELL PUBLISHING, INC
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2009 John Wiley & Sons A/S
• Final Published Version (URL): http://dx.doi.org/10.1111/j.1600-0714.2009.00749.x
• Title of Journal or Parent Work: JOURNAL OF ORAL PATHOLOGY & MEDICINE
• Volume: 38
• Issue: 6
• Start Page: 481
• End Page: 488
• Grant/Funding Information: Sources of Support: NIH/NIDCR/NIAID U01 AI 68636
• Keywords: PROTEASE INHIBITOR THERAPY; OPPORTUNISTIC INFECTIONS; Dentistry, Oral Surgery & Medicine; HUMAN-IMMUNODEFICIENCY-VIRUS; epidemiology; BISEXUAL MEN; AIDS; HAIRY LEUKOPLAKIA; IMMUNE SUPPRESSION; Pathology; DIAGNOSTIC-CRITERIA; ACTIVE ANTIRETROVIRAL THERAPY; Life Sciences & Biomedicine; HIV; Science & Technology; oral lesions; SAN-FRANCISCO; HIV VIRAL LOAD
• Research Categories: Health Sciences, Pathology; Biology, Virology

Abstract

The Oral HIV/AIDS Research Alliance (OHARA) is part of the AIDS Clinical Trials Group (ACTG), the largest HIV clinical trials organization in the world. Its main objective is to investigate oral complications associated with HIV/AIDS as the epidemic is evolving, in particular, the effects of antiretrovirals on oral mucosal lesion development and associated fungal and viral pathogens. The OHARA infrastructure comprises: the Epidemiologic Research Unit (at the University of California San Francisco), the Medical Mycology Unit (at Case Western Reserve University) and the Virology/Specimen Banking Unit (at the University of North Carolina). The team includes dentists, physicians, virologists, mycologists, immunologists, epidemiologists and statisticians. Observational studies and clinical trials are being implemented at ACTG-affiliated sites in the US and resource-poor countries. Many studies have shared end-points, which include oral diseases known to be associated with HIV/AIDS measured by trained and calibrated ACTG study nurses. In preparation for future protocols, we have updated existing diagnostic criteria of the oral manifestations of HIV published in 1992 and 1993. The proposed case definitions are designed to be used in large-scale epidemiologic studies and clinical trials, in both US and resource-poor settings, where diagnoses may be made by non-dental healthcare providers. The objective of this article is to present updated case definitions for HIV-related oral diseases that will be used to measure standardized clinical end-points in OHARA studies, and that can be used by any investigator outside of OHARA/ACTG conducting clinical research that pertains to these end-points. © 2008 Blackwell Munksgaard.