The purpose of this application is to continue the Newark AIDS Clinical Trials Unit (ACTU), established in 1987 as a participant in the AIDS Clinical Trials Group (ACTG) funded by NIAID. The primary research objective of the proposal is the evaluation of the pharmacokinetics, safety, tolerance and efficacy of agents to reduce the rate of perinatal transmission, develop effective antiretroviral treatment of primary HIV infection, and develop effective treatment and prophylaxis of opportunistic infections. In addition, the following objectives will also be pursued under this initiative: a) development and evaluation of new immunologic and virologic methods and their application to pediatric and perinatal clinical trials, b) evaluation of neurologic and neuropsychological tools and methods and their application to pediatric and perinatal clinical trials, c) enhancement Or outreach and recruitment of adolescents into clinical trials, d) enhancement of enrollment of minority and drug using women into clinical trials and the evaluation of gender-specific issues in this population.
The research aims of this proposal will be accomplished through participation in a multicenter national clinical trials network in which principal investigator work collectively and cooperatively with NIAID staff to devise and implement the most appropriate study for these objectives. Since the start of the Newark ACTU, a total of 180 patients have been enrolled into a variety of pediatric, perinatal and adult protocols in Newark. The ACTU has been a flagship pediatric center with an excellent record of recruitment, protocol management, patient compliance/retention, data quality and scientific contributions and accomplishments. ACTU investigators have been leaders in the group and in variety of trials including primary antiretrovrral protocols, OI studies and perinatal protocols. Under this application a network of five geographically diverse NJ trials centers will form a consortium which will increase access to trials and increase the population of potential patients. The laboratory of the ACTU has been singularly accomplished in supporting protocols and has also contributed significantly to the scientific accomplishment of the ACTG. Through this initiative the immunology and virology components will continue to serve as an important resource locally as well as nationally and will be involve in the development of new tests for application to trials. While the focus of the group is in perinatal and antiretroviral trials in children, investigators will also pursue trials in adolescents, minority and drug using women and will study new approaches to neurologic and neuropsychological evaluation of children participating in trials.
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