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A randomized clinical trial of valacyclovir in multiple sclerosis

Department of Neurology, New York University School of Medicine NY, NY 10010, USA, Laboratory of Clinical Immunology and Microbiology, The Rockefeller University, NY, NY 10021, USA, jef4{at}med.nyu.edu

J B Zabriskie

Laboratory of Clinical Immunology and Microbiology, The Rockefeller University, NY, NY 10021, USA

C Plank

Laboratory of Clinical Immunology and Microbiology, The Rockefeller University, NY, NY 10021, USA

D Ablashi

Advanced Biotechnologies, Inc., Columbia, MD 21046, USA

J Whitman

Advanced Biotechnologies, Inc., Columbia, MD 21046, USA

B Shahan

Department of Statistics, GlaxoSmithKline, Research Triangle Park, NC 27709, USA

R Edgell

Department of Neurology, NYU Medical Center, NY, NY 10016, USA

M Shieh

Laboratory of Clinical Immunology and Microbiology, The Rockefeller University, NY, NY 10021, USA

O Rapalino

Department of Neurology and Neuroradiology, NYU Medical Center, NY, NY 10016, USA

R Zimmerman

Department of Neuroradiology, Cornell Medical Center NY, NY 10021, USA

D Sheng

Division of Biostatistics, Department of Environmental Medicine, NYU Medical Center, NY, NY 10016, USA

Objective: The human Herpesvirus type-6 (HHV-6) has been implicated in multiple sclerosis (MS). Valacyclovir is an antiviral agent with an excellent safety profile. A two-year, placebo-controlled, double-blind study was conducted to (1) ascertain if high-dose, prolonged treatment with valacyclovir would be safe and (2) observe if valacyclovir would delay the progression of MS clinically or by magnetic resonance imaging (MRI). Design/methods: Fifty-eight patients were stratified as to severity and randomly assigned to receive valacyclovir (3000 mg/day) or placebo for a period of two years. Patients were followed clinically over the two-year period by means of the Expanded Disability Status Scale (EDSS), the Ambulation Index (AI) and brain MRI scans. Patients underwent routine lab studies every three months. Patients continued on the medication for two years unless they had a sustained progression or repeated exacerbations. Results: No patient discontinued the study due to side effects or toxicity. In Relative Ranking of Progression, time to first attack, attack rate, and time to withdrawal there were trends (but not statistically significant) toward drug effect over placebo in the Severe clinical category. MRI evaluation showed no significant drug effect. Conclusions: Although not statistically significant, positive trends were detected for acyclovir by clinical measures, but not by MRI.

Key Words: antiviral drugs • clinical trials • herpesvirus 6 • human antivirals • multiple sclerosis (MS)

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