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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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... more

Also known as:

  • 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)

Medical trial

ClinicalTrials.gov Identifier:

  • NCT00478465

Sponsor:

Type of trial:

Design:

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Phase:

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Eligibile genders:

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Minimum age for eligibility:

  • 18

Eligibility inclusion criteria:

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

Eligibility exclusion criteria:

  • Patients with Hb ≤ 10 g/dl
  • Patients with any other known chronic viral orbacterial infection for which other treatment(s) is(are) available
  • Women in childbearing age considering getting pregnant during the study period
  • Patient is a lactating female who will not discontinue nursing prior to study entry
  • Patient is simultaneously participating in another clinical trial
  • Previous hypersensitivity or contraindication to Valganciclovir/ganciclovir
  • Patients with ANC ≤1500 /mm3
  • 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 history of substance abuse in the past year (excluding nicotine and caffeine) or positive urine test for substance abuse
  • Patient requires the use of any prohibited concomitant medications (see Insert on VALCYTE prescribing information)

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Diseases:

Treatment being tested:

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