The overall goal of this project is to design and implement clinical studies of the treatment of Pneumocystis carinii pneumonia in patients with HIV infection and the acquired immunodeficiency syndrome (AIDS). In the first part of the project a generic protocol will be developed which can be used to conduct prospective, controlled, double-blind trials of drugs in the therapy of first episodes of PCP. These trials will be cooperative studies involving multiple institutions. The protocol will involve comparison of the efficacy and toxicity of a new drug with a standard administered to hospitalized patients for 14-21 days. Alpha-Difluoromethyl-ornithine (DFMO) and pentamidine isethionate will serve as the new and standard drugs, respectively, in the first trial. Fiberoptic bronchoscopy with broncho-alveolar lavage will be performed at the beginning and end of therapy, and analysis will be performed on PC organism number and viability. The treatment protocol is designed as a sequential clinical trial with data analysis being done every two months. A Performance and Safety Monitoring Committee will be established to monitor the study. Data obtained from these studies will lead to a more organized and efficient approach to the evaluation of new anti-PCP drugs, as well as a more accurate assessment of the effects of these agents on the organism.

Project Start
Project End
Budget Start
Budget End
Support Year
5
Fiscal Year
1992
Total Cost
Indirect Cost
Name
University of Cincinnati
Department
Type
DUNS #
City
Cincinnati
State
OH
Country
United States
Zip Code
45221
Grady, Benjamin J; Torstenson, Eric S; McLaren, Paul J et al. (2011) Use of biological knowledge to inform the analysis of gene-gene interactions involved in modulating virologic failure with efavirenz-containing treatment regimens in ART-naïve ACTG clinical trials participants. Pac Symp Biocomput :253-64
Sherman, Kenneth E; Rouster, Susan D; Stanford, Sandra et al. (2010) Hepatitis C virus (HCV) quasispecies complexity and selection in HCV/HIV-coinfected subjects treated with interferon-based regimens. J Infect Dis 201:712-9
Bhattacharya, Debika; Umbleja, T; Carrat, F et al. (2010) Women experience higher rates of adverse events during hepatitis C virus therapy in HIV infection: a meta-analysis. J Acquir Immune Defic Syndr 55:170-5
Zhao, Yu; Navia, Bradford A; Marra, Christina M et al. (2010) Memantine for AIDS dementia complex: open-label report of ACTG 301. HIV Clin Trials 11:59-67
Fichtenbaum, Carl J; Yeh, Tzu-Min; Evans, Scott R et al. (2010) Treatment with pravastatin and fenofibrate improves atherogenic lipid profiles but not inflammatory markers in ACTG 5087. J Clin Lipidol 4:279-87
Winham, Stacey J; Slater, Andrew J; Motsinger-Reif, Alison A (2010) A comparison of internal validation techniques for multifactor dimensionality reduction. BMC Bioinformatics 11:394
Butt, Adeel A; Tsevat, Joel; Leonard, Anthony C et al. (2009) Effect of race and HIV co-infection upon treatment prescription for hepatitis C virus. Int J Infect Dis 13:449-55
Tsevat, Joel; Leonard, Anthony C; Szaflarski, Magdalena et al. (2009) Change in quality of life after being diagnosed with HIV: a multicenter longitudinal study. AIDS Patient Care STDS 23:931-7
Skowron, Gail; Spritzler, John G; Weidler, Jodi et al. (2009) Replication capacity in relation to immunologic and virologic outcomes in HIV-1-infected treatment-naive subjects. J Acquir Immune Defic Syndr 50:250-8
Velilla, P A; Shata, M T; Lages, C S et al. (2008) Effect of low-dose IL-2 immunotherapy on frequency and phenotype of regulatory T cells and NK cells in HIV/HCV-coinfected patients. AIDS Res Hum Retroviruses 24:52-61

Showing the most recent 10 out of 123 publications