This proposal is for establishment of an AIDS Clinical Study Group in Central New Jersey whose major thrust will be development and evaluation of new anti-HIV compounds. A regional network of Infectious Disease clinicians who are members of the Division of Infectious Diseases at UMDNJ-Robert Wood Johnson Medical School and its affiliated hospitals has been organized into a Study Group. Based on data to date, it is anticipated that 300-400 cases of AIDS and proportional numbers of ARC and seropositive individuals will be seen in 1987 alone. In addition, a strong group of basic scientists at RWJMS will be involved in the pre-clinical development of novel forms of therapy for HIV infection, and will interact with and support the clinical studies with state-of-the- art immunologic and virologic techniques. The clinical trials to be undertaken will be 1) treatment of adult AIDS (CDC Group IV) with 2', 3""""""""-dideoxycytidine-DDC (Phase I safety and pharmacokinetics, then a randomized trial of DDC compared to azidothymidine), 2) a placebo-controlled trail of DDC IN HIV seropositives (CDC Groups II and III), and 3) an evaluation of adjunctive steroid therapy in AIDS patients with PCP. The basic research projects proposed deal with 1) sequence analysis of HIV and the origin of heterogeneity, 2) development of sensitive methods for detection of HIV nucleic acid, and evaluation of the anti-HIV activity of 3) anti-sense RNA and oligonucleotides, 4) a wide gamut of some 20 recombinant and natural human interferons, and 5) of detoxified bacterial lipopolysaccharides. In addition, basic clinical and epidemiologic research is proposed 1) in hemophiliacs and their contacts and 2) on the immunologic factors involved in the acquisition and progression of pediatric HIV infection. These projects will be supported by several core units which will provide 1) administrative services and coordination of clinical trials, 2) HIV culture, 3) immunologic profiles, and 4) pharmacy service.
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