Study of Ampligen in Chronic Fatigue Syndrome

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

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.

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). 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 within the four (4) weeks prior to the first study medication infusion. 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.
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 onset of CFS/ME) of a negative antinuclear antibody test (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.

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 immunomodulatory drugs (including gamma globulin, systemic steroids, interferons), antivirals (including acyclovir, AZT and/or other antiviral nucleoside analogues) or investigational drugs within the past 6 weeks. Subjects must give written informed consent prior to discontinuation of any medications.
5. Necessity to continue aspirin or other nonsteroidal anti-inflammatory drugs for thirty (30) consecutive days or for more than 20% of study duration.