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

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.

Figure 1

Fungal infections: (a) Pseudomembranous candidiasis on the lower labial mucosa; (b) erythematous candidiasis on the dorsum of the tongue and angular cheilitis at the corners of the mouth.

Figure 2.

Viral infections: (a) Hairy leukoplakia on the right lateral border of tongue; (b) herpes labialis (arrows show ulcers that have coalesced at a later stage of recurrent herpes infection); (c) recurrent intraoral herpes simplex on left hard palate; (d) multiple warts seen on upper labial mucosa.

Figure 3

Idiopathic conditions: (a) Minor aphthous ulcer on lower labial mucosa (note red hallo); (b) major aphthous ulcers on lower labial mucosa (note red hallo); for both minor and major aphthous ulcers, patient reports longterm history recurrence; (c) ulceration not otherwise specified (NOS); patient reports no history of recurrence.

Figure 4.

Bacterial infections: Necrotizing ulcerative periodontitis in the lower anterior segment.

Figure 5.

Salivary gland disease: Bilateral parotid enlargement.

Figure 6.

Neoplasms: (a) Early stage Kaposi’s sarcoma on upper left gingiva; (b) advanced stage Kaposi’s sarcoma on upper right hard palate; (c) non‐Hodgkin’s lymphoma on right soft palate; (d) squamous cell carcinoma on right lateral posterior tongue.