Valganciclovir (Valcyte) for Chronic Fatigue Syndrome Patients Who Have Elevated Antibody Titers Against Human Herpes Virus 6 (HHV-6)and Epstein-Barr Virus (EBV)

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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.

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NCT00478465

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Females of childbearing potential will have a negative pregnancy test at screening
Patient agrees to utilize two reliable methods of contraception combined throughout the study period and for 90 days following discontinuation of the Study Drug
Patient understands and signs the Informed Consent
Patients who had a "viral onset" for their CFS
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
Patients whose CFS symptoms are not spontaneously improving and have plateau for at least 6 months
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)

Edit	Eligibility exclusion criteria

Patient is a lactating female who will not discontinue nursing prior to study entry
Patient is simultaneously participating in another clinical trial
Patient requires the use of any prohibited concomitant medications (see Insert on VALCYTE prescribing information)
Patients receiving other experimental therapy
Patients taking other antiviral medications or who have received antiviral medications within the previous three months
Patients who are found to have alternate medical and/or psychiatric causes for their fatigue (see guidelines established by the International Chronic Fatigue Syndrome Study Group in 1994
Patients with abnormal creatinine clearance (≤60ml/min)
Patients with an active concurrent acute infection
Patients with ANC ≤1500 /mm3
Patients with any other known chronic viral orbacterial infection for which other treatment(s) is(are) available
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Created by midness Jul 17, 2008

Last edited by midness Jul 17, 2008

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