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Ampligen in Chronic Fatigue Syndrome

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ClinicalTrials.gov Identifier: NCT00215813
Expanded Access Status : Available
First Posted : September 22, 2005
Last Update Posted : May 2, 2022
Information provided by (Responsible Party):
AIM ImmunoTech Inc.

Tracking Information
First Submitted Date September 16, 2005
First Posted Date September 22, 2005
Last Update Posted Date May 2, 2022
Descriptive Information
Brief Title Ampligen in Chronic Fatigue Syndrome
Brief Summary This is an open label study of Ampligen in patients with chronic fatigue syndrome.
Detailed Description An Open-Label Study of Poly I: Poly C12U (Ampligen®) in Patients with Severely Debilitating Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME). The FDA approved the study for cost recovery. Patients enrolled in the study are responsible for costs related to the therapy, e.g., drug cost, infusion cost, cost of supplies, diagnostic and other laboratory testing.
Study Type Expanded Access
Expanded Access Type Intermediate-size Population, Treatment IND/Protocol
Intervention Drug: Poly I: Poly C12U (Rintatolimod)
200-400 mg IV infusions given twice weekly over a period of 30-60 minutes
Other Names:
  • Ampligen
  • Rintatolimod
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Available
Contact: Diane Young 352-448-7797 diane.young@aimimmuno.com
Contact: Ann Marie Coverly 352-448-7797 annmarie.coverly@aimimmuno.com
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT00215813
Current Responsible Party AIM ImmunoTech Inc.
Original Responsible Party Not Provided
Current Study Sponsor AIM ImmunoTech Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Principal Investigator: Daniel Peterson, M.D. Sierra Internal Medicine
Principal Investigator: Charles W. Lapp, M.D. Hunter-Hopkins Center, P.A.
PRS Account AIM ImmunoTech Inc.
Verification Date April 2022