This project encompasses all statistical coordinating center responsibilities for collaborative clinical studies undertaken by this Section. Currently the major collaborative clinical study is a double-blind clinical trial, designed to compare the efficacy of two different daily doses of zidovudine in the treatment of mild/moderate/severe AIDS Dementia Complex (ADC). It is a collaborative trial between the National Institute of Neurological Disorders and Stroke (NINDS), the National Naval Medical Center (NNMC), and Naval Hospital, Oakland. The major objective of the trial is to compare the effects of two different daily doses of zidovudine on the rate of progression of HIV-1 infection of the brain. The trial is designed to determine if zidovudine at a reduced dose offers a therapeutically effective alternative to zidovudine at 1250 mg daily dose in the management of patients with mild/moderate/severe ADC. One hundred twenty-four patients will be enrolled, 62 in each of two treatment arms. All patients will either be Department of Defense (DOD) health care beneficiaries who meet established criteria for ADC stage 1 (mild), stage 2 (moderate), or stage 3 (severe) and who are currently being treated/monitored at Naval hospitals in Bethesda or Oakland, or non-DOD health care beneficiaries with stage 1,2, or 3 ADC who reside in the Washington-Baltimore area and are under the care of local private practitioners. All patients will be followed for one year from the time of enrollment with periodic studies to monitor their response to the dose assigned. These studies will include routine clinical evaluations to detect adverse response to the drug as well as specialized clinical, neuropsychological, imaging, neurochemical, neurovirologic, and immunologic studies to measure the efficacy of the drug regimens employed in this trial.
