Each year there are ~40-60,000 new HIV infections in the United States with ~1.1 million persons living with HIV. There are many important unresolved management issues including the optimal antiretroviral treatment strategy at different stages of HIV disease, treatment of co-morbidities and minimizing of drug-associated toxicities. The University of Cincinnati AIDS Clinical Trials Unit (UC ACTU) has been an NIAID-funded AIDS Clinical Trials Group (ACTG) site since 1987. In this application the UC ACTU proposes to establish a Clinical Trials Unit (CTU) and Clinical Research Site (CRS) affiliated with the ACTG leadership application. This highly-experienced CTU, which was 5th in overall accrual and 3rd in cost per weighted accrual among 34 main ACTG units over the last 3 years, will continue to build upon its exemplary performance, scientific and resource committee contributions to provide leadership within a world-class clinical trials network (ACTG) with the scientific goals of developing new therapeutic approaches (translational research/drug development);optimizing clinical management including toxicities and co-morbidities;preventing maternal-child transmission;and vaccine research and development. To accomplish the goals of the ACTG the UC ACTU will: 1) Establish an administrative core CTU including a principal investigator, clinical trials manager, regulatory manager, data/Quality assurance manager, staff training and education, specimen processing, community outreach and administrative support to provide oversight, coordination and scientific expertise required to operate a high-performing CTU that will interface with the overall agenda/work of the ACTG;2) Contribute to the ACTG scientific agenda by enrolling subjects in studies, generating new proposals participating in study teams and committees to advance the work of the group;3) Establish a CRS that can maintain 20 subjects on study per month with the capability of following 100 subjects annually focusing enrollment on under-represented populations and utilizing the highest standards of good clinical practice for clinical research units. Thus, the UC ACTU, led by Dr. Judith Feinberg, an experienced HIV clinical researcher with support from leading experts in the fields of hepatitis (Dr. Ken Sherman) and HIV associated dyslipidemia/ cardiovascular disease (Dr. Carl Fichtenbaum), will contribute to the improvement in the lives of those with HIV infection through its excellence in clinical research. ADMINISTRATIVE COMPONENT:

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI069513-05
Application #
7996032
Study Section
Special Emphasis Panel (ZAI1-TP-A (M3))
Program Officer
Roth, Lynnea L
Project Start
2007-01-19
Project End
2013-11-30
Budget Start
2010-12-01
Budget End
2011-11-30
Support Year
5
Fiscal Year
2011
Total Cost
$1,635,950
Indirect Cost
Name
University of Cincinnati
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
041064767
City
Cincinnati
State
OH
Country
United States
Zip Code
45221
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Verma, Shefali S; Frase, Alex T; Verma, Anurag et al. (2016) PHENOME-WIDE INTERACTION STUDY (PheWIS) IN AIDS CLINICAL TRIALS GROUP DATA (ACTG). Pac Symp Biocomput 21:57-68
Moore, Carrie B; Verma, Anurag; Pendergrass, Sarah et al. (2015) Phenome-wide Association Study Relating Pretreatment Laboratory Parameters With Human Genetic Variants in AIDS Clinical Trials Group Protocols. Open Forum Infect Dis 2:ofu113
Gupta, S K; Kitch, D; Tierney, C et al. (2015) Markers of renal disease and function are associated with systemic inflammation in HIV infection. HIV Med 16:591-8
Luque, Amneris E; Cohn, Susan E; Park, Jeong-Gun et al. (2015) Depot medroxyprogesterone acetate in combination with a twice-daily lopinavir-ritonavir-based regimen in HIV-infected women showed effective contraception and a lack of clinically significant interactions, with good safety and tolerability: results of the Antimicrob Agents Chemother 59:2094-101
Longenecker, Chris T; Kitch, Douglas; Sax, Paul E et al. (2015) Reductions in Plasma Cystatin C After Initiation of Antiretroviral Therapy Are Associated With Reductions in Inflammation: ACTG A5224s. J Acquir Immune Defic Syndr 69:168-77
Firnhaber, Cynthia; Smeaton, Laura M; Grinsztejn, Beatriz et al. (2015) Differences in antiretroviral safety and efficacy by sex in a multinational randomized clinical trial. HIV Clin Trials 16:89-99
Wanga, Valentine; Venuto, Charles; Morse, Gene D et al. (2015) Genomewide association study of tenofovir pharmacokinetics and creatinine clearance in AIDS Clinical Trials Group protocol A5202. Pharmacogenet Genomics 25:450-61
Lehmann, David S; Ribaudo, Heather J; Daar, Eric S et al. (2015) Genome-wide association study of virologic response with efavirenz-containing or abacavir-containing regimens in AIDS clinical trials group protocols. Pharmacogenet Genomics 25:51-9
Vardhanabhuti, Saran; Ribaudo, Heather J; Landovitz, Raphael J et al. (2015) Screening for UGT1A1 Genotype in Study A5257 Would Have Markedly Reduced Premature Discontinuation of Atazanavir for Hyperbilirubinemia. Open Forum Infect Dis 2:ofv085

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