OHARA is part of the ACTG network, which is the largest HIV/AIDS clinical trial organization in the world and which plays a major role in defining the standards of care for treatment of HIV infection and opportunistic diseases related to HIV/AIDS (ACTG, 2011
). The ACTG’s mission is to develop and conduct scientifically rigorous translational research and therapeutic clinical trials in the United States and internationally—specifically, (1) to investigate the viral and immune pathogenesis of HIV-1 infection and its complications; (2) to evaluate novel therapeutic agents and the most effective approaches and strategies for the use of existing agents to treat HIV-1 infection; and (3) to evaluate interventions and strategies to treat and prevent HIV-related opportunistic infections, coinfections, complications of therapies, and other HIV-1-related comorbidities. The ACTG network comprises a leadership group that oversees, through an executive committee, the network laboratories, a coordinating and operations center, statistical and data management centers, scientific and resource committees, and 54 clinical trial units and clinical research sites.
The OHARA infrastructure comprises an epidemiology research unit at the University of California–San Francisco, a medical mycology unit and repository at Case Western Reserve University, and a virology unit and repository at the University of North Carolina. These centers were initially selected by the National Institute of Dental and Craniofacial Research, the National Institute of Allergy and Infectious Diseases, and the ACTG because of their complementary expertise in conducting large epidemiologic studies on the natural history of HIV/AIDS oral diseases in the United States and Africa and in deciphering the oral pathogenesis of fungal and viral infections in the setting of HIV/AIDS disease. In the joint National Institute of Allergy and Infectious Diseases–National Institute of Dental and Craniofacial Research funding opportunity announcement, the ACTG leadership established oral candidiasis, oral manifestations of Kaposi sarcoma, and oral manifestations of the human papilloma virus and herpes group virus infections as the areas of greatest clinical importance and relevance to the ACTG scientific agenda. The herpes group virus of interest included cytomegalovirus, Kaposi sarcoma herpesvirus, Epstein-Barr virus, and herpes simplex virus.
The OHARA Scientific Committee is a subcommittee of the ACTG Optimization of Coinfection and Comorbidity Management Scientific Committee (). OHARA investigators include dentists specialized in oral medicine, physicians (including infectious disease specialists), virologists, mycologists, immunologists, epidemiologists, and statisticians. The OHARA Scientific Committee includes a steering committee composed of the principal investigators of the 3 units (C. Shiboski at University of California San Francisco, M. Ghannoum at Case, and J. Webster-Cyriaque and D. Dittmer at the University of North Carolina), the director of the AIDS and Immunosuppression Program at the National Institute of Dental and Craniofacial Research (I. Rodriguez-Chavez), representatives from the ACTG Optimization of Coinfection and Comorbidity Management Scientific Committee and the Statistical Data Analysis Center, and a clinical trial specialist and committee coordinator from the operations center. In addition to the steering committee members, the OHARA Scientific Committee comprises a medical officer from the Division of AIDS at the National Institute of Allergy and Infectious Diseases, representatives from each ACTG scientific committee, the data management center, the 3 units, the international committee, the ACTG Community Advisory Board, and clinical research site field representatives. In addition, OHARA has a representative on each ACTG scientific committee. This infrastructure provides optimal integration, communication, and work effectiveness within the ACTG.
The Oral HIV/AIDS Research Alliance (OHARA) within the infrastructure of the AIDS Clinical Trial Group (ACTG). OHARA is funded by the National Institutes of Health and National Institute of Allergy and Infectious Diseases through the ACTG network.