Ampligen in Chronic Fatigue Syndrome (NCT00215813) | Clinical Trial Compass
TEMPORARILY_NOT_AVAILABLENot Applicable
Ampligen in Chronic Fatigue Syndrome
United States
Plain-language summary
This is an open label study of Ampligen in patients with chronic fatigue syndrome.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.).
. Age Range: \>= 18 years old, \<= 70 years old.
. 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.
. 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).
. Ability to provide written informed consent indicating awareness of the investigational nature of this study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. Laboratory confirmed negative SARS-CoV-2 (COVID-19) infection by a government approved test / kit within 2 weeks prior to starting study drug dosing.
. 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
. Inability to return for scheduled treatment and assessments.
. Chronic or intercurrent acute medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe.
. Pregnant or lactating females.
. 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.