The Oral HIV/AIDS Research Alliance: Overview and Scientific Agenda

Background/Objectives: The Oral HIV/AIDS Research Alliance (OHARA) is part of the AIDS Clinical Trials Group (ACTG), the world's largest HIV clinical trials organization. OHARA's main objective is to investigate the oral complications associated with HIV/AIDS as the epidemic is evolving, in particular the effects of antiretroviral agents on the development of oral mucosal lesions and associated fungal and viral pathogens.

Methods: The OHARA infrastructure comprises: the Epidemiological Research Unit (University of California San Francisco), the Medical Mycology Unit (Case Western Reserve University), and the Virology/Specimen Banking Unit (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 internationally. Many studies have shared end-points, which include oral mucosal diseases known to be associated with HIV/AIDS, measured by trained ACTG study nurses.

Results: To-date comprehensive modules for standardized training and calibration, and case definitions have been developed. OHARA is engaged in two protocols within ACTG and the AIDS Malignancy Consortium (aimed at assessing the immunogenicity, safety, and tolerability of the quadrivalent human papillomavirus recombinant vaccine) to study HPV shedding in saliva before and after vaccine administration, and comparing oral and anogenital shedding. For the OHARA component, 75 women and 100 men are being recruited and followed for 72 weeks. A third OHARA protocol is being developed to recruit 360 HIV-infected adults to validate oral diagnoses made by ACTG nurses and explore the use of saliva in monitoring HIV-RNA load.

Conclusion: In addition to investigating the oral complications associated with HIV/AIDS, OHARA will permit the development of a comprehensive oral infection and disease database and an HIV/AIDS oral specimen bank that will provide valuable material for future epidemiologic and biological research questions.

Supported by NIH/NIDCR/NIAID U01 AI 68636.