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Sponsored by: |
Stanford University |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00478465 |
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 |
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Chronic Fatigue Syndrome |
Drug: valganciclovir |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 0 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | August 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305 |
Principal Investigator: | Jose G Montoya, MD | Stanford University |
Study ID Numbers: | MV21103 Version 3.0 |
Study First Received: | May 23, 2007 |
Last Updated: | August 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00478465 History of Changes |
Health Authority: | United States: Food and Drug Administration |
chronic fatigue syndrome fatigue valganciclovir valcyte Epstein-Barr virus |
EBV Human herpes virus 6 HHV 6 herpes viruses herpes |
Fatigue Valganciclovir Central Nervous System Diseases Ganciclovir Encephalomyelitis Fatigue Syndrome, Chronic Antiviral Agents Virus Diseases |
Signs and Symptoms Antibodies Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Myalgic Encephalomyelitis Immunoglobulins |
Anti-Infective Agents Fatigue Disease Valganciclovir Nervous System Diseases Central Nervous System Diseases Ganciclovir Encephalomyelitis Fatigue Syndrome, Chronic Antiviral Agents |
Pharmacologic Actions Virus Diseases Signs and Symptoms Muscular Diseases Pathologic Processes Musculoskeletal Diseases Neuromuscular Diseases Therapeutic Uses Syndrome |