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Ampligen in Chronic Fatigue Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00215813
Expanded Access Status : Available
First Posted : September 22, 2005
Last Update Posted : June 7, 2023
Information provided by (Responsible Party):
AIM ImmunoTech Inc.

Brief Summary:
This is an open label study of Ampligen in patients with chronic fatigue syndrome.

Condition or disease Intervention/treatment
Chronic Fatigue Syndrome Drug: Poly I: Poly C12U (Rintatolimod)

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.

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population, Treatment IND/Protocol
Official Title: An Open-Label Study Of Poly I:Poly C12U (AMPLIGEN®) in Patients With Severely Debilitating Chronic Fatigue Syndrome (CFS)

Intervention Details:
  • 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Diagnosis of Chronic Fatigue Syndrome (>= 12 months) as defined by the 1988 Centers for Disease Control and Prevention CDC case definition for CFS or as defined only by the 1994 CDC case definition of CFS (Fukuda et al., Ann Intern Med. 1994; 121:953-959) (other clinical conditions which could present with similar symptoms must be excluded.).
  2. Age Range: >= 18 years old, <= 70 years old.
  3. Males or non-pregnant, non-lactating females: Females must be of non-child bearing potential (either post-menopausal for two years or surgically sterile including tubal ligation) or using an effective means of contraception (birth control pills, intrauterine device, diaphragm). Alternatively, female patients with a male partner having a successful vasectomy (considered successful if a volunteer reports that a male partner has either documentation of azoospermia by microscopy or a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy).Females who are less than two (2) years post-menopausal, those with tubal ligations and those using contraception must have a negative serum pregnancy test at baseline within the four (4) weeks prior to the first study medication infusion. Every four weeks, and at study termination a pregnancy test should be performed, either serum or urine stick test. However, if the urine result is positive, a serum pregnancy test will be performed. Females of child bearing potential agree to use an effective means of contraception from four (4) weeks prior to the baseline pregnancy test until four (4) weeks after the last study medication infusion. All male patients agree not to be a sperm donor and to use an effective means of contraception while on study medication and until 90 days after the last study medication infusion.
  4. A reduced quality of life as determined by a Karnofsky performance score (KPS) of >= 20 and <= 60. The KPS must be rounded in increments of ten (10).
  5. Ability to provide written informed consent indicating awareness of the investigational nature of this study.
  6. Documentation (during baseline or historically following the onset of CFS) of a negative ANA or a negative anti-ds (double-stranded) DNA, a negative Rheumatoid Factor, and an erythrocyte sedimentation rate (ESR). Documentation during baseline of a normal T4 (or other laboratory evidence that subject is euthyroid) is also required.
  7. Laboratory confirmed negative SARS-CoV-2 (COVID-19) infection by a government approved test / kit within 2 weeks prior to starting study drug dosing.
  8. Patients with post-COVID-19 chronic fatigue (PCCF) must meet the 1988 or 1994 CFS CDC Definition for Chronic Fatigue Syndrome except for the duration of the fatiguing illness which must have continued for at least 3 months and must not have preceded the onset of the COVID-19 symptoms. The patient must also have at least one of the following "Long Hauler" symptoms which must have persisted or recurred during 3 or more consecutive months of illness and must not have preceded the onset of the COVID-19 symptoms (fever or chills, cough, shortness of breath or difficulty breathing, new loss of taste or smell or chest pain). Since many patients with mild or no COVID-19 symptoms were not tested for the presence of SARS-CoV-2, many patients with post-COVID-19 chronic fatigue (PCCF) also called "Long Haulers", will not have a history of a positive SARS-CoV-2 test result. A positive serum antibody test for SARS-CoV-2 will be sufficient in these cases.

Exclusion Criteria:

  1. Inability to return for scheduled treatment and assessments.
  2. Chronic or intercurrent acute medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe.
  3. Pregnant or lactating females.
  4. Therapy with interferons, interleukins, or other cytokines or investigational drugs within 6 weeks of beginning study medication. Subjects must give written informed consent prior to discontinuation of investigational drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00215813

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Contact: Diane Young 352-448-7797
Contact: Ann Marie Coverly 352-448-7797

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United States, Nevada
Sierra Internal Medicine Available
Incline Village, Nevada, United States, 89451
Contact: Brielle Bjorke, PhD    775-831-4818   
Principal Investigator: Daniel Peterson, MD         
United States, North Carolina
Hunter-Hopkins Center, PA Available
Charlotte, North Carolina, United States, 28210
Contact: Wendy Springs, CCRP    704-543-9692   
Principal Investigator: Charles Lapp, MD         
Sponsors and Collaborators
AIM ImmunoTech Inc.
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Principal Investigator: Daniel Peterson, M.D. Sierra Internal Medicine
Principal Investigator: Charles W. Lapp, M.D. Hunter-Hopkins Center, P.A.
Additional Information:
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Responsible Party: AIM ImmunoTech Inc. Identifier: NCT00215813    
Other Study ID Numbers: AMP 511
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: June 7, 2023
Last Verified: June 2023
Keywords provided by AIM ImmunoTech Inc.:
Chronic Fatigue Syndrome
poly I:poly C12U
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuroinflammatory Diseases
Nervous System Diseases
Neuromuscular Diseases
Poly I-C
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs