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| Sponsor: | Stanford University |
|---|---|
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00478465 |
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 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 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Jose G Montoya, MD | Stanford University |
More Information
| 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 |
|
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 |