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Research Article

A Double-Blind, Placebo-Controlled, Randomized, Clinical Trial of the TLR-3 Agonist Rintatolimod in Severe Cases of Chronic Fatigue Syndrome

  • David R. Strayer mail,

    david.strayer@hemispherx.net (DRS); bill.mitchell@vanderbilt.edu (WMM)

    Affiliation: Hemispherx Biopharma, Inc., Philadelphia, Pennsylvania, United States of America

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  • William A. Carter,

    Affiliation: Hemispherx Biopharma, Inc., Philadelphia, Pennsylvania, United States of America

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  • Bruce C. Stouch,

    Affiliation: BCS Consulting, Philadelphia, Pennsylvania, United States of America

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  • Staci R. Stevens,

    Affiliation: University of the Pacific, Stockton, California, United States of America

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  • Lucinda Bateman,

    Affiliation: Fatigue Consultation Clinic, Salt Lake City, Utah, United States of America

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  • Paul J. Cimoch,

    Affiliation: Center for Special Immunology, Fountain Valley, California, United States of America

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  • Charles W. Lapp,

    Affiliation: Hunter-Hopkins Center, Charlotte, North Carolina, United States of America

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  • Daniel L. Peterson,

    Affiliation: Sierra Internal Medicine Associates, Incline Village, Nevada, United States of America

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  • the Chronic Fatigue Syndrome AMP-516 Study Group,

    For a list of the members of Chronic Fatigue Syndrome AMP-516 Clinical Study Group please see Table S2.

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  • William M. Mitchell mail

    david.strayer@hemispherx.net (DRS); bill.mitchell@vanderbilt.edu (WMM)

    Affiliation: Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America

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  • Published: March 14, 2012
  • DOI: 10.1371/journal.pone.0031334

About the Authors

David R. Strayer, William A. Carter
Hemispherx Biopharma, Inc., Philadelphia, Pennsylvania, United States of America
Bruce C. Stouch
BCS Consulting, Philadelphia, Pennsylvania, United States of America
Staci R. Stevens
University of the Pacific, Stockton, California, United States of America
Lucinda Bateman
Fatigue Consultation Clinic, Salt Lake City, Utah, United States of America
Paul J. Cimoch
Center for Special Immunology, Fountain Valley, California, United States of America
Charles W. Lapp
Hunter-Hopkins Center, Charlotte, North Carolina, United States of America
Daniel L. Peterson
Sierra Internal Medicine Associates, Incline Village, Nevada, United States of America
William M. Mitchell
Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America

Corresponding Authors

Competing Interests

LB, BCS, RNP and CWL have consulted for, or received lecture fees from Hemispherx Biopharma. All clinical investigators received support budgets from Hemispherx Biopharma for the conduct of the clinical trial to support the New Drug Application (NDA) of Ampligen (rintatolimod) for the treatment of CFS. DRS, the Medical Director, and WAC, the CEO, of Hemispherx, both own stock and options in Hemispherx Biopharma. WAC and WMM are members of the Board of Directors for Hemispherx Biopharma and own stock and options. SRS has received non-rintatolimod related grant support from the CFIDS Association of America. A patent for the use of rintatolimod for CFS was granted to Hemispherx during the conduct of this study (patent number is 6,130,206 and the date is October 10, 2000). Hemispherx has several patents pending for CFS. This does not alter the authors' adherence to all the PLoS ONE policies on sharing data and materials.

Author Contributions

Conceived and designed the experiments: DRS WAC. Performed the experiments: SRS LB PJC CWL DLP. Analyzed the data: DRS WAC BCS WMM. Contributed reagents/materials/analysis tools: BCS SRS. Wrote the paper: DRS WMM.