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Research Studies

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 is designed to provide CFS patients with micronutrients (amino acids, antioxidants, and mitochondrial cofactors) designed to complement the low-dose CNS stimulant medication (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 tolerated.

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. Enrollment is currently scheduled to last until September 1, 2014 and the results are expected in early 2015. Research sites currently include:

  • 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.

Forty 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 (P=0.01).




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.



Boosts Alertness & Enhances Productivity. Improves Fatigue. Can also be used as a Complete Daily Multivitamin.


Our Story

Twenty years ago, during the height of the AIDS epidemic, our company began studying how to naturally improve the immune systems of people with HIV/AIDS...

More Info
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Chronic fatigue much improved!

Kathy C. - Pleasanton, CA
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