A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Valganciclovir (Valcyte) in Patients Experiencing Chronic Fatigue Syndrome With Elevated Antibody Titers Against Human Herpesvirus-6 (HHV-6) and Epstein-Barr Virus (EBV)
The purpose of this study determine whether the drug valganciclovir has a significant and real benefit on the central core of symptoms experienced by patients who have high titers to EBV and HHV-6 and are experiencing long-standing fatigue and cognitive impairment (CFS). In addition, to characterize a quantifiable biological marker in these patients that will facilitate the identification of those likely to respond to valganciclovir and will make it possible to assess response to treatment.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : valganciclovir
Phase: Phase 1/Phase 2
Ages Eligible For Study:
1. Adult patients (? 18 years old). 2. Patient understands and signs the Informed Consent. 3. Patients who meet the clinical criteria for the diagnosis of chronic fatigue syndrome as established by the International Chronic Fatigue Syndrome Study Group in 1994 . 4. Patients who had a "viral onset" for their CFS. 5. Patients whose CFS symptoms are not spontaneously improving and have plateau for at least 6 months. 6. Patients with "high" antibody titers against HHV-6 IgG ? 640, EBV VCA IgG ? 640 and detectable EA Ab at 1:160 or HHV-6 IgG ? 320 if EBV VCA IgG ? 1280 and has detectable EA Ab at 1:160 (measured by the average of a minimum of two time points obtained during screening at least 3 weeks apart). 7. Patient agrees to utilize two reliable methods of contraception combined throughout the study period and for 90 days following discontinuation of the Study Drug. 8. Females of childbearing potential will have a negative pregnancy test at screening.
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