Carbohydrate-derived fulvic acid wellness drink : its tolerability, safety and effect on disease markers in pre-ART HIV-1 positive subjects

Abstract

BACKGROUND : Many people take wellness drinks on a daily basis to enhance physical and emotional well-being. The safety and/ or efficacy of these are not always known or even established in the populations likely to consume these. The safety, tolerability and clinical impact of CHD-FA in a formulated wellness drink (F0210) (a pure and novel fulvic acid) were researched in a pre-ART HIV-1 positive population in India an area where patients are known to use organic acids such as fulvic acids (Shilajit) for health enhancement. METHODS : This double-blind, placebo-controlled, parallel study recruited 332 patients (n = 166 on active; n = 166 on placebo). The study outcomes recorded safety and tolerability data, as well as the time to ART and/or the time to a decrease in CD4 count of 100 cells/mm3 for subjects in each treatment group. Change in immune status is an important clinical endpoint. The secondary outcomes were CD4 count, HIV-1 viral load changes and quality of life (the latter as a further proxy for tolerability). RESULTS : The only notable side effect of the active medication was gastrointestinal intolerance such as diarrhoea, nausea and vomiting, which were more frequently experienced compared with placebo. The study was terminated before full recruitment due to regulatory changes in India and at the time of study termination there were too few clinical study endpoints reached to demonstrate any clinical difference between active and placebo treatments (no difference in hazard of experiencing an event (reaching indication for ART) between groups; p = 0.5724). An interesting trend was that patients’ CD4 counts in the study demonstrated a slower than anticipated decline compared with trends recorded in the literature for natural progression of disease. CONCLUSION : The CHD FA wellness drink is well tolerated in an ART-naive study population and does not negatively affect the disease-specific parameters and hence does not adversely affect the natural progression of the HIV-1 disease or patients’ general health. Further exploration of fulvic acids is therefore warranted.