Four highly experienced and successful domestic Clinical Research Sites (CRS) will form the HIV Centers for Underrepresented Populations in REsearch (HIV CURE) CTU. The CTU will be located at the University of California San Diego (UCSD) with Stephen A. Spector serving as the PI. The 4 CRSs are located at Baylor College of Medicine in Houston (William T. Shearer, Leader), Lurie Children's Hospital in Chicago (Northwestern - Ram Yogev, Leader), St. Jude Children's Research Hospital/University of Tennessee in Memphis (Patricia Flynn, Leader), and UCSD (SA Spector, Leader). These 4 CRSs have demonstrated the ability to enroll subjects into protocols involving numerous clinical trials networks including IMPAACT, ACTG, PHACS, ATN, INSIGHT, AERAS and DMID. These CRSs represent 4 of the 5 the highest accruing sites and the 4 highest CRSs in scientific contribution to the IMPAACT Network.
The Specific Aims of the HIV CURE CTU are: 1. Evaluate the pharmacokinetics, safety, and drug interactions of new and existing antiretroviral agents and formulations; 2. Evaluate novel approaches for tuberculosis prevention, treatment and diagnosis; 3. Develop and test biomedical/behavioral interventions to prevent HIV transmission between infected youth and their sexual partners and mother-to-child transmission (MTCT); 4. Evaluate the immunogenicity, safety and efficacy of vaccines of high priority in HIV-infected women, pregnant women, infants, children and youth; 5. Evaluate potential for HIV cure through therapeutic interventions aimed at prevention and clearance of HIV reservoirs; 6. Evaluate the pharmacokinetics, safety, and efficacy of new drugs and drug combinations to treat hepatitis B (HBV) and hepatitis C (HCV); and 7. Determine optimal and feasible methods for the prevention and management of complications of HIV infection and its treatment. The HIV Cure CTU will use its extensive capacity to recruit subjects into the IMPAACT, ACTG and HPTN Networks HIV-infected and at-risk populations that are historically underrepresented in clinical trials including minorities and people of color with an emphasis on women, pregnant women, youth, children and newborns which will broaden the applicability of clinical trials performed within the DAIDS networks.
This CTU application combines 4 highly experienced and successful domestic CRSs to form the HIV Centers for Underrepresented Populations in Research (HIV CURE) CTU that will focus on recruitment to studies of the IMPAACT, ACTG and HPTN Networks HIV-infected and at-risk minority subjects with an emphasis on women, pregnant women, youth, children and newborns. Thus, this application is highly relevant to this RFA.
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