Pitt-Ohio State Clinical Trials Unit Administrative Supplement

PROJECT SUMMARY/AIMS, Parent Award AI069494The Specific Aims of the Pitt-Ohio State Clinical Trials Unit (CTU) are: Aim 1.To advance thescientific agenda of the ACTG by developing and implementing high-priority research studies askey protocol team members, by serving on major Leadership and Scientific Committees, and bydirecting the ACTG Laboratory Center (LC) Virology Core and an ACTG Immunology SupportLaboratory. The ACTG scientific areas of focus for the Pitt-Ohio State CTU will be HIV Reservoirsand Viral Eradication (HIV Cure), Hepatitis, and End-organ Disease and Inflammation. Work onTuberculosis will be limited to PK and drug interaction studies. Aim 2.To advance the scientificagenda of the MTN by developing and implementing high-priority research studies as key protocolteam members, by serving on major Leadership and Scientific Committees, and by directing theMTN LC Virology Core. The MTN scientific areas of focus for the CTU will be the safety andefficacy of vaginal rings containing one or more antiretrovirals, rectal microbicides, andcombination approaches (HIV vaccines plus oral PrEP or microbicides). Aim 3.To rapidly expandexisting CTU capacity into new areas of HIV and antimicrobial resistance research to meet theevolving needs of the DAIDS- and DMID-sponsored Networks. Aim 4.To provide access toDAIDS-sponsored clinical trials for the hard-to-reach and impoverished populations mostimpacted by the HIV/AIDS epidemic in western Pennsylvania, central Ohio, and Appalachia (WestVirginia, and southeastern Ohio), where no other access to trials exists. Aim 5.To recruit, enroll,retain and monitor study participants in high-priority protocols of the ACTG, MTN, HPTN, andHVTN, and to meet and exceed performance standards established by these Networks. Aim 6.Topartner with affected communities and community advisory boards at each CRS throughout theseendeavors. Aim 7.To mentor promising young investigators identified at each CRS to becomeskilled researchers. The Specific Aims of the project have been adjusted to reflect the de-fundingof the Georgetown University CRS.