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Lauric Acid Clinical Trials For People Living With HIV/AIDS
 
 

Lauric.org is seeking a sponsor for a U.S. six month, three-site, proof-of-concept trial that they are developing based on newly designed lauric/capric acid protocols for HIV/AIDS (A-0114) and Mother-Infant HIV Transmission (A-0118). 

In lipid coated virus (LCV) and lipid coated bacterium (LCB) research, a proof-of-concept clinical trial is an 

organized study conducted on people with specific LCVs such as HIV or LCBs such as listeria monocytogenes. The trial seeks to answer specific questions about new treatments and new ways of using treatments. The proof-of-concept clinical trial studies monoglycerides and may also look at them as adjunct to existing drugs already used for the treatment of LCVs and LCBs. The trial also looks at how changes in dietary intake of monoglycerides can help patients prevent LCVs and LCBs from occurring. 
 
The trial seeks to answer specific questions about new treatments and new ways of using treatments. 
Lauric.org has a Proof-of-Concept Trial Preliminary Budget Cost Form on its web site for institutions to fill out if they are interested in participating and would like to be considered as a possible site. The proposed HIV/AIDS (A-0114) Proof-of-Concept Trial will use pharmacologically naive participants and those individuals whom have failed treatment. The six-month study will test the use of lauric fats in the diet as physiologically functional foods to lower viral load and P24 antigen in HIV-infected individuals and to raise CD4 T-cells and/or CD4/CD8 T-cell ratios. The study will also determine subjective sense of well-being. Participants must be HIV-positive with an elevated viral load that is sufficiently elevated so that a measure of reduction could be determined. They must have a low CD4 T-cell count or a low CD4/CD8 value. HIV-positive individuals on many drugs including protease inhibitors and whose viral loads have been reduced to a level that is not measurable are excluded from the study. After the determination of laboratory values, participants will receive a supply of lauric fats previously determined to contain sufficient amounts of lauric and capric acid to provide 24-28 grams and 3-4 grams per person per day, respectively.

For more information on the Proof-of-Concept Trial and lauric acid visit <http://www.lauric.org/>.

Source: HIV/AIDS Clinical Trials. Lauric.org Homepage. Bethesda, MD: Center For Research On Lauric Oils, Inc. WWW: http://www.lauric.org/ (accessed 8 June 2001).
 

HAART And Anemia
 

Richard Semba and colleagues recently conducted a longitudinal study of HIV-infected intravenous drug users (IVDUs) in Baltimore, Maryland to examine the potential impact of highly active antiretroviral therapy (HAART) on anemia. Previous studies have shown that 15 to 30 percent of HIV-infected drug users may have anemia. A variety of etiologic factors are implicated in anemia including antiretroviral therapy, micronutrient deficiencies, anemia of chronic diseases, etc. Semba and colleagues thought that HAART may either worsen anemia, through increased bone marrow toxicity, or improve it through potential mechanisms, such as the improvement in micronutrient status or reduction of opportunistic infections (OIs) and associated anemia of chronic disease. 

Investigators enrolled 102 subjects who received HAART and 103 control subjects who did not receive antiretroviral medications. Participants had a CD4+ lymphocyte count of less than 500 cells/l in 1996. Hemoglobin, measured at baseline and at two subsequent visits, was low in 40% of the participants at baseline. Participants not receiving HAART had a mean decrease in hemoglobin of