application's abstract): The applicants propose to continue their multidisciplinary multi-year research program, that will integrate institutional expertise in infectious diseases, neurology, ophthalmology, gynecology, pharmacology, immunology, retrovirology, herpes viruses, and numerous clinical resources in North Carolina. The main focus is the evaluation of novel therapies for HIV-infected persons. Clinical investigators at the UNC and two satellite units, Greensboro, and Charlotte will study new compounds active against HIV and associated infections, malignancies, and neurologic disorders in new patients and follow previously enrolled patients. This proposes to continue a high rate of accrual among minorities, women, and intravenous (I.V.) drug users. The trials will be of all Phases (I, II, and III) and types. Patients will be followed for in vivo evidence of study drug effects on HIV, Mycobacterium avium intracellular complex (MAC), cytomegalovirus (CMV), herpes simplex virus (HSV), and other opportunistic infections using the ACTG-certified retrovirology and immunology virus laboratory, as well as UNC hospital laboratories. Pharmacokinetics (PK) will be monitored in the General Clinical Research Center (GCRC) and Microbiology and Pharmacology Laboratories. Concepts for new protocols will originate by participation in the Executive, Neurology, and Complications of HIV, HIV Pharmacology and Immunology ACTG committees. The established scientific advisory board (SAB) also will be involved in concept development. The UNC group application has new proposals for many trials including the eradication of HIV, simplification of regimens, novel therapies, improving adherence and immune restoration. Outreach to the community may be accomplished through the community advisory boards (CAB) at each site, the website and through a statewide newsletter. Finally, low protocol costs may be maintained by cost sharing with NIH grants (GCRC, Pediatric ACTU, Center for AIDS Research (CFAR), as well as with UNC Hospitals, and the Departments of Medicine, Neurology, Ophthalmology, Microbiology and School of Pharmacy.
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