1998 Clinical and Scientific Meeting

Charles W. Lapp, M.D. and Cynthia S.Voyles, A.N.P., M.S.N.

Duke University Medical School, Durham, North Carolina, and
Hunter-Hopkins Center, P.A., Charlotte, North Carolina, USA

Overview of Ampligen Therapy

Double-stranded RNA has been used for the treatment of veterinary viral infections for over 3 decades, but was considered too toxic for human use. The inclusion of a uridine molecule in one of the strands, however, makes the molecule quite safe for human use. Poly(I):Poly(C12U), or Ampligen, has been shown to be both antiviral and immunomodulatory in human beings.

Initial studies have demonstrated considerable efficacy and safety in the treatment of chronic fatigue syndrome (CFS). An open-label study of Ampligen involving 15 subjects who met the 1988 CDC Criteria for CFS was begun in 1988. Over 24 weeks of therapy with Ampligen, general performance scores and cognition improved progressively, and HHV-6 reactivation was significantly reduced. Based on this pilot study, a randomized, placebo-controlled, double-blind, multicenter study of Ampligen was undertaken in 1989. Again, general performance and cognition improved as did activities of daily living and exercise treadmill performance.

This presentation will review the pharmacology of Ampligen, as well as the pilot study and the randomized trial. We will describe current trials of Ampligen in the US and Europe, particularly our experience with five subjects in Charlotte.


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