The long term objective of this project is to develop new, more effective therapies for human immunodeficiency virus (HIV)- infected patients with malignancies. Specifically, we plan to create a Tulane AIDS-Associated Malignancy Consortium (AMC) site, which will develop and carry out clinical trials directed at therapy of these tumors. The AMC, a national cooperative group made up of several HIV and/or cancer research institutions, will design pilot, phase I and II trials based on hypotheses generated by investigators from the member sites. Data will be centrally collected and analyzed, and the conclusions will be disseminated via professional meetings and journals. Based on the projected local incidence of these tumors, the Tulane site will enroll a minimum of 30 patients per year to AMC clinical trials. This estimate is derived from Tumor Registry data and demographic information from the New Orleans HIV Outpatient Program. Tulane has a long history of active participation in cooperative clinical trials groups involving both cancer and HIV, and the proposed AMC site will be organized based on the local model that has proven successful in these groups. Tulane will also contribute to the development of new hypotheses from which clinical trials can be designed. Specific unique contributions of the proposed site include the ability to successfully enroll HIV-infected women to clinical trials, as well as expertise with translational research, particularly in the area of gene therapy for cancer.
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