Chronic Fatigue Syndrome Research Program
There currently exists no FDA approved
treatment for Chronic Fatigue Syndrome (CFS). K-PAX Pharmaceuticals
is currently developing what we hope will become the first by-prescription
treatment for this condition. A multi-center double-blind, placebo-controlled
trial, called the Synergy Trial, is currently enrolling patients.
The Synergy Trial will evaluate
the safety and efficacy of a currently available medication (methylphenidate)
combined with a CFS-specific dietary supplement (CFS Nutrient Formula) to
treat Chronic Fatigue Syndrome (CFS).
Preliminary data used to design this treatment used K-PAX IMMUNE at a dosage of 4 tablets twice daily as the CFS Nutrient Formula.
The CFS Nutrient Formula to be used in
the Synergy Trial is a 2nd generation micronutrient supplement that provides CFS
patients with vitamins, minerals, and other cofactors (amino acids,
antioxidants, and mitochondrial cofactors) to complement the low-dose
CNS stimulant (methylphenidate). In other words, therapeutic dosages of
micronutrients are provided to support the functioning of the nervous,
endocrine, and immune systems to a level at which a low dose of methylphenidate
can produce positive clinical effects on CFS symptoms and also be well
The Synergy Trial
will enroll 120 participants at four (4) separate research sites throughout the
United States. The duration of the study intervention is 12-weeks. Sites
- Palo Alto, CA (Stanford University)
- Manhattan, NY
- Salt Lake City, UT
- (to be determined)
For more information on how to enroll in The Synergy Trial call 1-855-318-HOPE (4673) or click here
HIV/AIDS Research Program
For more information on the ongoing Canadian HIV/AIDS Study (The MAINTAIN Study) using K-PAX IMMUNE for people with early HIV infection, which is currently enrolling patients, please click here.
K-PAX IMMUNE was the micronutrient formula tested in a double-blinded, placebo-controlled clinical trial which demonstrated a positive effect on the immune systems of HIV(+) individuals on antiviral therapy.
HIV-infected patients taking a stable antiviral medication regimen were
randomized to either the K-PAX formula or placebo groups. After 12
weeks, the patients taking the K-PAX formula experienced an average 24%
increase in their CD4 count compared to no change in the placebo group
The mean absolute CD4 count also rose significantly by an average of 65 cells after 12 weeks in the micronutrient group versus a 6 cell decline in the placebo group (P=0.029).
This research study was presented at the 2006 World AIDS Conference in Toronto (Abstract #0402). It was also published in the August 2006 issue of the Journal of Acquired Immune Deficiency Syndromes (JAIDS) - Kaiser JD, et al. JAIDS 2006;42(5):523-528.
To download a copy of this study directly from the Journal of AIDS website click here
K-PAX IMMUNE and ENERGY are dietary supplements and are not indicated for the diagnosis, prevention, or treatment of any medical condition. Individual results may vary.