The analysis of two separate longitudinal observational datasets will generate preliminary data about Clinical, laboratory, and quality of life (QOL) health outcomes associated with the use of complementary and alternative medical (CAM) therapies in HIV+ men and women. Data collection has ended in both of these studies, and only completion of data management, data validation and analysis are proposed. The two studies were designed to screen the most frequently used treatments for benefit or harm by comparing outcomes of CAM treatments with one another and with concurrent pharmaceutical anti-viral therapy. The primary outcome variables for both studies were changes in CD4+ T lymphocytes, HIV-1 peripheral blood levels, body mass index, the health status scales of the HIV Medical Outcomes Survey, progression rate to clinical AIDS, and survival rates. Secondary outcome variables are the incidence and prevalence of disease related symptoms and diagnoses. The two studies are: I) the Alternative Medical Care Outcomes in AIDS (AMCOA) study which during 10/95 to 10/97 enrolled 1689 HIV+ men and women nationwide who were identified as using CAM therapies for HIV disease. Data were collected until October 1998 semi-annually for up to two years on each participant. Further validation and completion of the survival analysis in the AMCOA study depends on a planned analysis of deaths. 2) Johns Hopkins and Bastyr collaborated in studying outcomes associated with CAM use in subjects enrolled in the Multicenter AIDS Cohort Study (MACS), a 14 year observational study of HIV+ men. 90% of the MACS participants reported at their 26th and 27th semi-annual visits about their use of any of 35 alternative treatments in the preceding 6 months, allowing health status changes over one year to be compared among treatment options. Though the two studies used somewhat different methodologies, some results from them can be compared to determine if significant findings in one study demonstrate a reflection in the other. The Center is seeking funding to complete analysis of both the AMCOA and Bastyr-Johns Hopkins MACS studies.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Research Project (R01)
Project #
1R01AT000251-01
Application #
6079314
Study Section
Special Emphasis Panel (ZRG1-AARR-6 (01))
Program Officer
Jackson, Morgan
Project Start
2000-05-08
Project End
2003-03-31
Budget Start
2000-05-08
Budget End
2003-03-31
Support Year
1
Fiscal Year
2000
Total Cost
$375,652
Indirect Cost
Name
Bastyr University
Department
Type
Organized Research Units
DUNS #
055652309
City
Kenmore
State
WA
Country
United States
Zip Code
98028
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Brumback, Babette; Greenland, Sander; Redman, Mary et al. (2003) The intensity-score approach to adjusting for confounding. Biometrics 59:274-85