The Clinical Trials Unit (CTU) at DSC was the number one performing Unit for relative cost per weighted accrual for the past 5 years, number two for % enrollment of minorities for the past three years and number two for overall accrual during the past 12 months (through 6/05). There are currently 103 study subjects on ACTG studies at USC. There are 63% Latinos and 27% women of the nearly 3000 patients attending the Rand Schrader Clinic, site of the USC CTU and CRS, which closely replicates our accrual to aACTG studies. The Site Evaluation Subcommittee (9/2004) highly commended the Unit on its exceptional performance for relative cost per weighted accrual, monitoring-source documentation, monitoring-endpoint determination, enrollment of Hispanics, laboratory shipping score, and timeliness of protocol registrations packets. As Dr. Sattler took over as Principal Investigator on 7/1/05, the CTU was reorganized. Several former ACTG, now mid-career investigators were recruited as Key Personnel, and several nationally renowned USC investigators with expertise in areas of high priority for Network research were included as Consultants and Collaborators. The primary goal of these changes was to augment the scientific contributions from the USC CTU with the expectation that the breadth and expertise of these investigators will provide a major impact in helping to shape the future CTN research agenda. This group of distinguished investigators includes 8 women and 5 faculty representing ethnic or racial minorities with expertise in clinical virology;immunology;mycology;tuberculosis;endocrinology/metabolism;hepatology;cardiology;adolescent and child care, women's health;and pharmacokinetics, pharmacodynamics and pharmacogenomics. Moreover, the USC CTU will continue its long-time commitment to the development of junior investigators, as Key Personnel will mentor 4 junior faculty or fellow-instructor trainees (2 women and 2 minority men) as CRS investigators in learning the principles of HIV clinical and translational research. Finally, this investigative group will allow the USC CTU/CRS to continue to perform at the same high level as in recent years in achieving the Network research agenda. They will also participate in ACTG group-wide meetings and contribute concept proposals for novel new treatment and prevention strategies to be tested in resource limited settings (e.g. East LA) that will often be applicable for the care of patients in developing countries. ADMINISTRATIVE COMPONENT:

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
5UM1AI069428-06
Application #
8197512
Study Section
Special Emphasis Panel (ZAI1-TP-A (M2))
Program Officer
Pouliot, Eileen M
Project Start
2007-07-01
Project End
2013-11-30
Budget Start
2011-12-01
Budget End
2012-11-30
Support Year
6
Fiscal Year
2012
Total Cost
$1,734,887
Indirect Cost
$670,539
Name
University of Southern California
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
072933393
City
Los Angeles
State
CA
Country
United States
Zip Code
90089
Grant, Philip M; Komarow, Lauren; Sanchez, Alejandro et al. (2014) Clinical and immunologic predictors of death after an acute opportunistic infection: results from ACTG A5164. HIV Clin Trials 15:133-9
Leger, Paul D; Johnson, Daniel H; Robbins, Gregory K et al. (2014) Genome-wide association study of peripheral neuropathy with D-drug-containing regimens in AIDS Clinical Trials Group protocol 384. J Neurovirol 20:304-8
Haas, David W; Kwara, Awewura; Richardson, Danielle M et al. (2014) Secondary metabolism pathway polymorphisms and plasma efavirenz concentrations in HIV-infected adults with CYP2B6 slow metabolizer genotypes. J Antimicrob Chemother 69:2175-82
Johnson, Daniel H; Venuto, Charles; Ritchie, Marylyn D et al. (2014) Genomewide association study of atazanavir pharmacokinetics and hyperbilirubinemia in AIDS Clinical Trials Group protocol A5202. Pharmacogenet Genomics 24:195-203
Touzard Romo, F; Smeaton, L M; Campbell, T B et al. (2014) Renal and metabolic toxicities following initiation of HIV-1 treatment regimen in a diverse, multinational setting: a focused safety analysis of ACTG PEARLS (A5175). HIV Clin Trials 15:246-60
Jacobson, Jeffrey M; Wang, Hongying; Bordi, Rebeka et al. (2014) A randomized controlled trial of palifermin (recombinant human keratinocyte growth factor) for the treatment of inadequate CD4+ T-lymphocyte recovery in patients with HIV-1 infection on antiretroviral therapy. J Acquir Immune Defic Syndr 66:399-406
Safren, Steven A; Biello, Katie B; Smeaton, Laura et al. (2014) Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial. PLoS One 9:e104178
Ribaudo, Heather J; Daar, Eric S; Tierney, Camlin et al. (2013) Impact of UGT1A1 Gilbert variant on discontinuation of ritonavir-boosted atazanavir in AIDS Clinical Trials Group Study A5202. J Infect Dis 207:420-5
Thio, Chloe L; Smeaton, Laura; Saulynas, Melissa et al. (2013) Characterization of HIV-HBV coinfection in a multinational HIV-infected cohort. AIDS 27:191-201
Brown, Todd T; Chen, Yun; Currier, Judith S et al. (2013) Body composition, soluble markers of inflammation, and bone mineral density in antiretroviral therapy-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr 63:323-30

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