This application will continue an existing AIDS clinical trials unit at Washington University as part of the Adult AIDS Clinical Trials Group, currently led by Dr. R. Schooley at the University of Colorado. The application projects the enrollment of 100 to 120 new patients in clinical trials each year, and the maintenance of an existing population of 100 to 150 patients in ongoing studies. The applicants plan to enroll patients in trials of primary HIV therapy including antiviral and immunotherapy and in studies on opportunistic infections, metabolic and neurological complications of HIV infection. Studies specifically designed for women also will be initiated. Approximately 70 to 80 percent of patients will be enrolled in studies primarily directed at the treatment of HIV infection, and 20 to 30 percent of patients will be enrolled in studies of the complications of HIV infection. In addition, this ACTU will contribute to the AACTG's ambitious scientific agenda by actively participating in substudies involving virologic, immunologic and pharmacologic laboratory substudies, detailed neurologic evaluation of patients enrolled in primary infection trials, and epidemiological and laboratory substudies for patients with opportunistic infection or metabolic problems. Scientifically, the ACTU investigators will focus on providing leadership in antiretroviral trials, specifically studies of salvage therapy for failing antiretroviral treatment or intensification of early failures. The applicants also will focus on complications of HIV infection, notably prophylaxis of opportunistic infection, and studies of the neurologic and metabolic complications of the disease and/or its treatment. The ACTU will continue to have two clinics with the main unit at the University medical center, and the second at St. Louis Connectcare. The latter, located at the only municipally supported health care facility in St. Louis, was specifically developed to increase access for minorities, drug-users, and other underrepresented individuals. The ACTU will maintain its successful efforts to match enrollment in trials to the demography of the epidemic in St. Louis. It is anticipated that at least 35 percent of enrollment will be from the African-American community and at least 10 percent will be women. The ACTU also will direct a substantial effort to communicating the goals and successes of clinical trials to the community, especially health care workers, and the Unit will continue to maintain an active Community Advisory Board.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01AI025903-14
Application #
6021926
Study Section
Special Emphasis Panel (ZAI1-PSS-A (S1))
Program Officer
Batzold, Frederick
Project Start
1987-09-30
Project End
2004-12-31
Budget Start
2000-01-01
Budget End
2000-12-31
Support Year
14
Fiscal Year
2000
Total Cost
$1,886,782
Indirect Cost
Name
Washington University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
062761671
City
Saint Louis
State
MO
Country
United States
Zip Code
63130
Cade, W Todd; Singh, Gautam K; Holland, Mark R et al. (2015) Maternal post-absorptive leucine kinetics during late pregnancy in US women with HIV taking antiretroviral therapy: a cross-sectional pilot study. Clin Nutr ESPEN 10:e140-e146
Clifford, David B (2015) Neurological immune reconstitution inflammatory response: riding the tide of immune recovery. Curr Opin Neurol 28:295-301
Kempen, John H; Sugar, Elizabeth A; Varma, Rohit et al. (2014) Risk of cataract among subjects with acquired immune deficiency syndrome free of ocular opportunistic infections. Ophthalmology 121:2317-24
Sacktor, Ned; Miyahara, Sachiko; Evans, Scott et al. (2014) Impact of minocycline on cerebrospinal fluid markers of oxidative stress, neuronal injury, and inflammation in HIV-seropositive individuals with cognitive impairment. J Neurovirol 20:620-6
Zhang, Xinyan; Tierney, Camlin; Albrecht, Mary et al. (2013) Discordant associations between SLCO1B1 521T?C and plasma levels of ritonavir-boosted protease inhibitors in AIDS clinical trials group study A5146. Ther Drug Monit 35:209-16
Kempen, John H; Sugar, Elizabeth A; Lyon, Alice T et al. (2012) Risk of cataract in persons with cytomegalovirus retinitis and the acquired immune deficiency syndrome. Ophthalmology 119:2343-50
Sacktor, N; Miyahara, S; Deng, L et al. (2011) Minocycline treatment for HIV-associated cognitive impairment: results from a randomized trial. Neurology 77:1135-42
Ribaudo, Heather J; Benson, Constance A; Zheng, Yu et al. (2011) No risk of myocardial infarction associated with initial antiretroviral treatment containing abacavir: short and long-term results from ACTG A5001/ALLRT. Clin Infect Dis 52:929-40
Shacham, Enbal; Hoffer, Lee; Overton, Edgar Turner (2011) Perceptions of alcohol risk among individuals living with HIV. AIDS Care 23:107-12
Puhan, Milo A; Ahuja, Alka; Van Natta, Mark L et al. (2011) Interviewer versus self-administered health-related quality of life questionnaires - does it matter? Health Qual Life Outcomes 9:30

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