/AIMS, Parent Award AI069494 The Specific Aims of the Pitt-Ohio State Clinical Trials Unit (CTU) are:
Aim 1. To advance the scientific agenda of the ACTG by developing and implementing high-priority research studies as key protocol team members, by serving on major Leadership and Scientific Committees, and by directing the ACTG Laboratory Center (LC) Virology Core and an ACTG Immunology Support Laboratory. The ACTG scientific areas of focus for the Pitt-Ohio State CTU will be HIV Reservoirs and Viral Eradication (HIV Cure), Hepatitis, and End-organ Disease and Inflammation. Work on Tuberculosis will be limited to PK and drug interaction studies.
Aim 2. To advance the scientific agenda of the MTN by developing and implementing high-priority research studies as key protocol team members, by serving on major Leadership and Scientific Committees, and by directing the MTN LC Virology Core. The MTN scientific areas of focus for the CTU will be the safety and efficacy of vaginal rings containing one or more antiretrovirals, rectal microbicides, and combination approaches (HIV vaccines plus oral PrEP or microbicides).
Aim 3. To rapidly expand existing CTU capacity into new areas of HIV and antimicrobial resistance research to meet the evolving needs of the DAIDS- and DMID-sponsored Networks.
Aim 4. To provide access to DAIDS-sponsored clinical trials for the hard-to-reach and impoverished populations most impacted by the HIV/AIDS epidemic in western Pennsylvania, central Ohio, and Appalachia (West Virginia, 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, and HVTN, and to meet and exceed performance standards established by these Networks.
Aim 6. To partner with affected communities and community advisory boards at each CRS throughout these endeavors.
Aim 7. To mentor promising young investigators identified at each CRS to become skilled researchers.
The Specific Aims of the project have been adjusted to reflect the de-funding of the Georgetown University CRS.
This supplement application is being provided in response to PA-18-591 and NOSI AI-20-031 and is responsive to a request from the Division of AIDS to expand patient and study participant testing for COVID-19/SARS-CoV.
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