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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00478465
First received: May 23, 2007
Last updated: August 29, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
Chronic Fatigue Syndrome
Drug: valganciclovir
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Estimated Enrollment: 0
Study Start Date: May 2007
Estimated Study Completion Date: August 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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 [10].
  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.

Exclusion Criteria:

  1. 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 [1].
  2. Patients with history of major depression with psychotic or melancholic features before the diagnosis of CFS or who are found to be actively depressed (major depression with psychotic or melancholic features) by the depression instrument used for the study and by a medical evaluation by a psychiatrist.
  3. Patients with other serious co-morbidities which according to the investigator may interfere with the ability of the patient to participate in the study
  4. Patients with history of substance abuse in the past year (excluding nicotine and caffeine) or positive urine test for substance abuse.
  5. Patients with any other known chronic viral orbacterial infection for which other treatment(s) is(are) available
  6. Patients with an active concurrent acute infection
  7. Patients with abnormal creatinine clearance (≤60ml/min)
  8. Patients with ANC ≤1500 /mm3
  9. Patients with Hb ≤ 10 g/dl
  10. Patients with platelet count ≤ 100 000/mm3
  11. Previous hypersensitivity or contraindication to Valganciclovir/ganciclovir
  12. Patients taking other antiviral medications or who have received antiviral medications within the previous three months
  13. Patients receiving other experimental therapy
  14. Patient is simultaneously participating in another clinical trial
  15. Patient requires the use of any prohibited concomitant medications (see Insert on VALCYTE prescribing information).
  16. Women in childbearing age considering getting pregnant during the study period
  17. Patient is a lactating female who will not discontinue nursing prior to study entry. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478465

Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jose G Montoya, MD Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00478465     History of Changes
Other Study ID Numbers: MV21103 Version 3.0
Study First Received: May 23, 2007
Last Updated: August 29, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
chronic fatigue syndrome
fatigue
valganciclovir
valcyte
Epstein-Barr virus
EBV
Human herpes virus 6
HHV 6
herpes viruses
herpes

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014