An estimated 700,000 people in the United States are infected with HIV. Effective treatment of HIV infection requires prolonged administration of multiple antiretroviral agents. Incorporating clinical pharmacology expertise into the design, performance, and analysis of HIV clinical trials is therefore essential. Establishment of a main AIDS Clinic Trial Unit (ACTU) at Vanderbilt University would bring extensive expertise in clinical pharmacology to the AIDS Clinic Trials Group (ACTG). Vanderbilt ACTU investigators will participate in several studies including: inter-individual variability in response to antiretroviral therapy; drug disposition and metabolism; drug-drug interactions; tissue delivery of protease inhibitors and other drugs by membrane transporters (including P-glycoprotein); and the application of ultra-intensive CSF sampling approaches to study HIV treatment and pathogenesis in the CNS. The investigators also may apply advanced mass spectroscopy techniques to HIV clinical trials. The use of state-of-the-art clinical pharmacology strategies to HIV clinical trials may ultimately improve treatment of HIV infection and its complications, and allow therapy to be appropriately individualized. Vanderbilt University investigators also will contribute expertise to other innovative HIV-related laboratory efforts. These include: developing novel antiretroviral therapeutics; studying HIV-1 virion assembly and HIV-1 accessory proteins; developing novel HIV-related assays; understanding viral pathogenesis of AIDS-related malignancies; characterizing host-pathogen interactions in the gastrointestinal tract during AIDS; and developing strategies to optimize the design of antiretroviral agents and AIDS vaccines. The Principal Investigator leads an established HIV clinical trials program at Vanderbilt University, and the proposed ACTU incorporates a large Vanderbilt- affiliated HIV primary care clinic. Technically demanding studies will be facilitated by the Vanderbilt University General Clinical Research Center (GCRC). The proposed ACTU will not only enroll patients into ACTG clinical trials, but will provide the ACTG the ability to address important questions concerning AIDS treatment and pathogenesis.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01AI046339-05S2
Application #
7150589
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Germuga, Donna E
Project Start
2000-01-01
Project End
2007-12-31
Budget Start
2006-01-01
Budget End
2007-12-31
Support Year
5
Fiscal Year
2006
Total Cost
$1,006,278
Indirect Cost
Name
Vanderbilt University Medical Center
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37212
Gupta, Samir K; Yeh, Eunice; Kitch, Douglas W et al. (2017) Bone mineral density reductions after tenofovir disoproxil fumarate initiation and changes in phosphaturia: a secondary analysis of ACTG A5224s. J Antimicrob Chemother 72:2042-2048
Verma, Anurag; Bradford, Yuki; Verma, Shefali S et al. (2017) Multiphenotype association study of patients randomized to initiate antiretroviral regimens in AIDS Clinical Trials Group protocol A5202. Pharmacogenet Genomics 27:101-111
Gammal, R S; Court, M H; Haidar, C E et al. (2016) Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for UGT1A1 and Atazanavir Prescribing. Clin Pharmacol Ther 99:363-9
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
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
Gupta, Samir K; Kitch, Douglas; Tierney, Camlin et al. (2014) Cystatin C-based renal function changes after antiretroviral initiation: a substudy of a randomized trial. Open Forum Infect Dis 1:ofu003
Erlandson, Kristine Mace; Kitch, Douglas; Tierney, Camlin et al. (2014) Impact of randomized antiretroviral therapy initiation on glucose metabolism. AIDS 28:1451-61
Wyatt, Christina M; Kitch, Douglas; Gupta, Samir K et al. (2014) Changes in proteinuria and albuminuria with initiation of antiretroviral therapy: data from a randomized trial comparing tenofovir disoproxil fumarate/emtricitabine versus abacavir/lamivudine. J Acquir Immune Defic Syndr 67:36-44
McComsey, Grace A; Kitch, Douglas; Sax, Paul E et al. (2014) Associations of inflammatory markers with AIDS and non-AIDS clinical events after initiation of antiretroviral therapy: AIDS clinical trials group A5224s, a substudy of ACTG A5202. J Acquir Immune Defic Syndr 65:167-74
Erlandson, Kristine M; Kitch, Douglas; Tierney, Camlin et al. (2013) Weight and lean body mass change with antiretroviral initiation and impact on bone mineral density. AIDS 27:2069-79

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