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Sunday, August 11, 2002

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Bastyr Unversity AIDS Research Center
Current Scientific Activities

Alternative Medical Care Outcomes in AIDS (AMCOA). A longitudinal observational database based on an extensive patient-completed questionnaire supported by laboratory records. AMCOA is intended to be preliminary information to guide future research. AMCOA has: 1.) established a network of cooperating alternative medicine clinics; 2.) recruited over 1500 HIV+ individuals across the U.S. who are using alternative medicine to participate in the study; 3.) collected clinical, laboratory and quality of life data for every six months on patients; and 4.) has developed a centralized database which allows for comparisons of outcomes among a variety of therapies. Subjects were recruited either via their alternative providers or by self-volunteering. Subject recruitment closed in September 1997.

The research is focused upon 1.) what are the differences in outcome variables associated with particular alternative therapies or combinations of therapies and 2.) are there differences in outcome variables for patients using only alternative medicine vs. those using both alternative and conventional medicine? There are 6 primary measures of outcome: 1) progression through CDC classes; 2) changes in CD4+ lymphocyte counts; 3) changes in health status; 4) weight changes; 5) changes in HIV RNA viral load; and 6) mortality.

1689 subjects have returned baseline questionnaires. Almost all subjects were followed for a one-year period with a portion completing two years. Data is currently being analyzed for the remaining follow-up data.

Multi-Center AIDS Cohort Study (MACS). NIAID's Multicenter AIDS Cohort Study (MACS) is a collaboration with the AIDS Research Center in order to assess CAM utilization and health outcomes associated with alternative medicine use among HIV+ MACS participants. The Bastyr-MACS collaboration provides an excellent opportunity to measure health outcomes associated with CAM use in a cohort from which complete clinical and laboratory data is obtained on a regular semi-annual basis.

The AIDS Research Center was permitted to insert a one-page questionnaire in the MACS questionnaire on two consecutive visits. The purpose of this collaboration is to: 1) determine if clinical, laboratory and quality of life outcomes are different in HIV+ men who use alternative medicine vs. those who do not and 2) investigate whether or not there are specific alternative therapies used by the MACS cohort that are associated with especially good (or poor) outcomes. 495 questionnaires were returned to BUARC. Data entry is close to completion and data analysis is presently occurring.

Distant Healing in HIV/AIDS (in collaboration with the Complementary Medicine Research Institute) The purpose of the proposed trial is to extend preliminary work by studying a much larger sample, examining additional biological markers of disease progression, and following medical and quality-of-life outcomes for a longer period. In addition, the study will compare distant healing (DH) efforts by professional "healers," with DH efforts by professional nurses with no previous DH training.

Anti-HIV Activity of Botanical Preparations The long-term objective of this research is to develop and implement a systematic in vitro testing strategy to evaluate botanical medicines for HIV/AIDS treatment. Botanical therapy is in wide use as a complementary and alternative medicine (CAM) strategy by HIV-infected individuals. Although CAM practitioners commonly prescribe combination botanical regimens to HIV positive patients, many of these agents have yet to be systematically evaluated for effectiveness, toxicity and interactions with highly active antiretroviral therapy (HAART). Furthermore, different extract preparations of these botanical agents may contain varying levels of constituents active against HIV replication. The prevalent use of botanical agents with non-standardized constituent levels by the HIV positive population calls for the systematic evaluation of anti-HIV activity of these agents for HIV/AIDS treatment. Therefore, we have brought together an interdisciplinary team of investigators to systematically evaluate the anti-HIV activity of five distinct, well-defined extract preparations of Glycyrrhiza glabra (licorice root) and Hypericum perforatum (St John's wort).

Garlic for hyperlipidemia caused by high active antiretroviral therapy (HAART). This is a phase I/II randomized double-blind, placebo controlled trial to study garlic as lipid lowering therapy in hyperlipidemic HIV-infected subjects treated with highly active antiretroviral therapy (HAART). We will utilize an allicin-standardized dried garlic supplement in three escalating in HIV-infected subjects who are receiving HAART. The primary aim of this study is to measure the effects of three escalating doses of the supplement on total serum cholesterol. Secondary aims include determining the tolerability and adverse events associated with three escalating doses of the supplement and gathering preliminary data on the effects on fasting serum triglycerides, basal glucose and insulin levels as well as serum transaminases (ALT and AST).

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