Ampligen in Chronic Fatigue Syndrome

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Expanded Access
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AIM ImmunoTech Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Daniel Peterson, M.D.Vincent F. Hillman, M.D.
Principal Investigator Affiliation Sierra Internal MedicineHunter-Hopkins Center, P.A.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Available
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Fatigue Syndrome
Study Website: View Trial Website
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sierra Internal Medicine, Incline Village, Nevada




Sierra Internal Medicine

Incline Village, Nevada, 89451

Site Contact

Brielle Bjorke, PhD

[email protected]


Hunter-Hopkins Center, PA, Charlotte, North Carolina




Hunter-Hopkins Center, PA

Charlotte, North Carolina, 28210

Site Contact

Wendy Springs, CCRP

[email protected]