Ampligen in Chronic Fatigue Syndrome

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

Study Description

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.

Study Design

• 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)

Interventions

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Diane Young; 352-448-7797; diane.young@aimimmuno.com

Contact: Ann Marie Coverly; 352-448-7797; annmarie.coverly@aimimmuno.com

Locations

United States, Nevada

Sierra Internal Medicine; Available

Incline Village, Nevada, United States, 89451

Contact: Brielle Bjorke, PhD 775-831-4818 bbjorke@sierrainteralmed.com

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 drlapp@drlapp.net

Principal Investigator: Charles Lapp, MD

Sponsors and Collaborators

AIM ImmunoTech Inc.

Investigators

• Principal Investigator: Daniel Peterson, M.D.; Sierra Internal Medicine
• Principal Investigator: Charles W. Lapp, M.D.; Hunter-Hopkins Center, P.A.

More Information

Additional Information:

research 

Publications:

Strayer DR, Carter WA, Stouch BC, Stevens SR, Bateman L, Cimoch PJ, Lapp CW, Peterson DL; Chronic Fatigue Syndrome AMP-516 Study Group; Mitchell WM. A double-blind, placebo-controlled, randomized, clinical trial of the TLR-3 agonist rintatolimod in severe cases of chronic fatigue syndrome. PLoS One. 2012;7(3):e31334. doi: 10.1371/journal.pone.0031334. Epub 2012 Mar 14.

Strayer DR, Young D, Mitchell WM. Effect of disease duration in a randomized Phase III trial of rintatolimod, an immune modulator for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. PLoS One. 2020 Oct 29;15(10):e0240403. doi: 10.1371/journal.pone.0240403. eCollection 2020.

• Responsible Party: AIM ImmunoTech Inc.
• ClinicalTrials.gov Identifier: NCT00215813
• Other Study ID Numbers: AMP 511
• First Posted: September 22, 2005
• Last Update Posted: May 2, 2022
• Last Verified: April 2022

Keywords provided by AIM ImmunoTech Inc.:

Chronic Fatigue Syndrome; CFS; ME; Ampligen; poly I:poly C12U; Rintatolimod

Additional relevant MeSH terms:

Fatigue Syndrome, Chronic; Syndrome; Fatigue; Disease; Pathologic Processes; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; poly(I).poly(c12,U); Poly I-C; Antiviral Agents; Anti-Infective Agents; Interferon Inducers; Immunologic Factors; Physiological Effects of Drugs