The Colorado AIDS Clinical Trials Unit (ACTU) was established in July 1990 as a subunit of the Harvard ACTU, under the direction of Dr. Robert Schooley. During this period an effective clinical trials infrastructure including clinical personnel, data management, and immunology and virology laboratory support has been developed independent of the Harvard ACTU. Since clinical trials were initiated on August 9, 1990 nearly 100 subjects have been enrolled into ACTG protocols at our site. The rapid accrual of subjects even in the absence of an active recruiting program underscores the enthusiasm of the Colorado HIV-infected community for participation in clinical trials at the only ACTU between St. Louis and San Francisco. We are now requesting support to establish the Colorado ACTU as an independent unit of the AIDS Clinical Trials Group. The Colorado ACTU will emphasize protocols in the areas of primary and opportunistic infection, oncology, and immune based therapy with a focus on studies involving early stages of drug development. The establishment of core laboratories in virology and pharmacology laboratories as components of the Colorado ACTU will enhance our ability to provide intensive laboratory support for the clinical studies proposed in this application. In addition, research projects in the areas of virology, immunology, pharmacology, and opportunistic pathogens are proposed, which will allow us to design and conduct more effective clinical trials in HIV-related disease. These laboratory activities will provide the opportunity to combine basic scientific investigation with carefully conducted clinical trials to expand our understanding of the interactions between HIV and its human host, with a particular emphasis on the role of HIV- and pathogen-specific immunity in the pathogenesis of AIDS.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
Special Emphasis Panel (SRC (75))
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Colorado Denver
Schools of Medicine
United States
Zip Code
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
Williams, Pl; Wu, Jw; Cohn, Se et al. (2009) Improvement in lipid profiles over 6 years of follow-up in adults with AIDS and immune reconstitution. HIV Med 10:290-301
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
Gerber, John G; Kitch, Douglas W; Fichtenbaum, Carl J et al. (2008) Fish oil and fenofibrate for the treatment of hypertriglyceridemia in HIV-infected subjects on antiretroviral therapy: results of ACTG A5186. J Acquir Immune Defic Syndr 47:459-66
Sattler, Fred R; Rajicic, Natasa; Mulligan, Kathleen et al. (2008) Evaluation of high-protein supplementation in weight-stable HIV-positive subjects with a history of weight loss: a randomized, double-blind, multicenter trial. Am J Clin Nutr 88:1313-21
Ma, Qing; Forrest, Alan; Rosenkranz, Susan L et al. (2008) Pharmacokinetic interaction between efavirenz and dual protease inhibitors in healthy volunteers. Biopharm Drug Dispos 29:91-101
Rosenkranz, Susan L; Yarasheski, Kevin E; Para, Michael F et al. (2007) Antiretroviral Drug Levels and Interactions Affect Lipid, Lipoprotein, and Glucose Metabolism in HIV-1 Seronegative Subjects: A Pharmacokinetic-Pharmacodynamic Analysis. Metab Syndr Relat Disord 5:163-73
Riddler, Sharon A; Jiang, Hongyu; Tenorio, Allan et al. (2007) A randomized study of antiviral medication switch at lower- versus higher-switch thresholds: AIDS Clinical Trials Group Study A5115. Antivir Ther 12:531-41
Margolis, David M; Mukherjee, A Lisa; Fletcher, Courtney V et al. (2007) The use of beta-D-2,6-diaminopurine dioxolane with or without mycophenolate mofetil in drug-resistant HIV infection. AIDS 21:2025-32
Fischl, Margaret A; Collier, Ann C; Mukherjee, A Lisa et al. (2007) Randomized open-label trial of two simplified, class-sparing regimens following a first suppressive three or four-drug regimen. AIDS 21:325-33

Showing the most recent 10 out of 55 publications