Ampligen in Chronic Fatigue Syndrome

October 28, 2025 updated by: AIM ImmunoTech Inc.

An Open-Label Study Of Poly I:Poly C12U (AMPLIGEN®) in Patients With Severely Debilitating Chronic Fatigue Syndrome (CFS)

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

Study Overview

Status

Temporarily not available

Conditions

Intervention / Treatment

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Incline Village, Nevada, United States, 89451
        • Sierra Internal Medicine
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Hunter-Hopkins Center, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIM ImmunoTech Inc.

Investigators

  • Principal Investigator: Daniel Peterson, M.D., Sierra Internal Medicine
  • Principal Investigator: Vincent F. Hillman, M.D., Hunter-Hopkins Center, P.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimated)

September 22, 2005

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMP 511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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