Neurologic AIDS Research Consortium

Clifford, David

Abstract

We will establish the """"""""Neurologic AIDS Research Consortium"""""""" (NARC) which will be a major contributor to neurologic projects in the AIDS Clinical Trial Group (ACTG). NARC will be dedicated to clinical investigation of human immunodeficiency virus (HIV) associated neurologic disease. The consortium initially will consist of sixteen units, established at ACTG sites combining neurologic leadership in the area of clinical AIDS research, access to subjects with HIV-related neurologic disease, and leadership within the local AIDS Clinical Trial Unit supportive of neurologic projects. This grant will supplement the resources of the ACTG system to achieve maximal productivity in the area of neurologic investigation. We will provide a network of support by supplying a base grant to establish coordination of the local neurologic effort and effective communication s and travel funds to effect a collaborative relationship in this group. The base grant will be supplemented on a per capita funding basis for successful study of subjects in clinical trials. The per capita funding will supplemental local ACTU support for extraordinary costs of neurologic studies and for professional time required to manage the study. We will coordinate our efforts through the leadership of NARC which will be located at Washington University in St. Louis. Statistical and data analysis for our studies will be carried out through the ACTG system, with supplemental support to the Harvard School of Public Health through this grant. The initial projects to be undertaken in the grant include: (1) Completion of the Phase I/II study of nimodipine as an adjunction to antiretroviral therapy in the treatment of HIV motor/cognitive disorder, (2) A study of the natural history of neurologic disease in advanced HIV patients identified by CD4 counts ,<50, with particular emphasis on neuropsychometric performance as a measure of disease progression, (3) A double-blind controlled study of amitriptyline and mexiletine in the treatment of HIV associated painful peripheral neuropathy, (4) A controlled clinical trial testing the efficacy of cytosine arabinoside for treatment of progressive multifocal leukoencephalopathy, and (5) a trial of combination chemotherapy and radiation therapy for treatment of HIV associated primary central nervous system lymphoma. It is anticipated that these studies will be followed by subsequent studies to further develop therapy related to these problems. The group also anticipates participation cytomegalovirus induced neurologic disease. Plans for future study and use of resources will be guided by the ACTG Neurology Scientific Committee with review by appropriate ACTG Scientific Committees and by the ACTG Executive Committee.