AEGiS-GMHC: Ampligen Update

Important note: Information in this article was accurate in 1991. The state of the art may have changed since the publication date.

Ampligen Update

TREATMENT ISSUES--The GMHC Newsletter of Experimental AIDS Therapies - Vol. 5, No. 1 - January 10, 1991
Gabriel Torres, M.D.

Ampligen is a synthetic form of RNA being studied in patients with cancers that manifest as solid tumors, chronic fatigue syndrome, and HIV infection. Since most RNA is single-stranded, except in certain viruses like HIV, Ampligen may be thought of as an agent which produces a positive immune response in the body, rather than a negative one. Ampligen has activity in the test tube against many viruses including CMV, herpes simplex, human herpes virus Type VI, hepatitis B, and HIV. In addition, Ampligen seems to increase interferon production which in turn stimulates antiviral activity in the immune system, such as the activation of natural killer cells and macrophages (white blood cells).

The results of an initial phase I Ampligen trial for seven patients with AIDS and ARC were published in 1987 in the Lancet. The study reported clinical improvements in immune functions such as, restoration of skin test reactivity, reduction of swollen lymph nodes and stabilization or increases in T4 cell counts. Ampligen may also decrease the actual amount of virus in some patients. After these phase I results were published, duPont Pharmaceuticals furnished the much needed funds and joined HEM Research Inc., Ampligen's manufacturer, to sponsor a phase II trial of the drug.

In the placebo-controlled phase II study, the significant effects of Ampligen as reported by the phase I trial were not reproduced. The Ampligen used in this later study was formulated in plastic bags for intravenous infusion. Such formulation, HEM claimed, produced a molecule of the drug with different physical and chemical properties than Ampligen prepared in glass bottles. When 20 patients who received Ampligen in the glass bottle formulation were compared to a group receiving placebo, the frequency of opportunistic infection and lymphomas (cancers) was statistically reduced in those receiving drug.

Subsequent studies of Ampligen by HEM have shown that the drug retains its activity if prepared and packaged in glass bottles instead of plastic bags. A follow-up unpublished study, conducted by Dr. William Carter showed a synergistic effect (a combined action of two or more drugs that is greater than either drug action on its own) by combining Ampligen and AZT in a group of 11 symptomatic ARC patients. Some of these participants experienced rises in T4 cell counts, which remained elevated for more than one year after the onset of the trial. Test tube experiments also suggest that Ampligen may reduce AZT-related bone marrow toxicity and prevent the emergence of AZT resistance. The side effects of Ampligen have been mild, consisting of light rashes, flushing and a mild flu-like syndrome which improves after several weeks of therapy.

New Hope for Ampligen?

HEM Research, Inc. is now conducting a multicenter, double blind, placebo controlled study of Ampligen at two doses (400 mg and 700 mg) in HIV-positive persons with T4 cell counts between 100-500 who are taking AZT (300-500 mg/day). Forty-five patients, continuing AZT therapy, will be assigned to either of the two doses of Ampligen, or placebo. Participants will receive intravenous infusion two times per week. Patients with previous AIDS-defining opportunistic infections or lymphoma are excluded since the objective of the study is to determine whether Ampligen decreases progression and stabilizes T4 cell counts, p24 antigen levels, and other measurements of immune function. The study will last 12 months and is being conducted at medical centers in New York, Philadelphia, Miami, Tampa, Houston, Dallas, Washington, D.C. and Portland, Oregon. The local centers include Hahnemann Medical Center in Philadelphia (Jeanine Thomas at (215) 448-8610); and St. Vincent's Hospital in New York City (Michael Thorn at (212) 790-7020, beeper # 2561 or at (212) 790-7625). For more information, contact HEM Research, Inc. at (215) 988-0080.

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Copyright © 1991 - Treatment Issues. Reproduced with permission. Treatment Issues is published twelve times yearly by GMHC, Inc. All rights reserved. Noncommercial reproduction is encouraged. Subscription lists are kept confidential. GMHC Treatment Issues, The Tisch Building, 119 West 24th Street, New York, NY 10011 fredg@gmhc.org http://www.gmhc.org

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