FDA Grants Hemocleanse Approval to Expand Hyperthermia Trials for AIDS Patients

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Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.

FDA Grants Hemocleanse Approval to Expand Hyperthermia Trials for AIDS Patients

PR Newswire (12/20/94)

The Food and Drug Administration (FDA) has granted Hemocleanse, Inc. conditional approval to expand its clinical investigation of the use of the BioLogic-HT machine in the whole body hyperthermia (WBHT) treatment of patients with AIDS. An initial study was conducted in July with three patients treated at 42 degrees Celsius and three patients treated at 40 degrees Celsius. The expanded study will involve 30 participants--20 who receive treatment at either 40 or 42 degrees Celsius and 10 control patients who receive no treatment. WBHT has been used as a treatment for certain kinds of cancers since the 1960s. The BioLogic-HT system induces a high artificial fever, while controlling necessary blood chemistries, thus diminishing the risks to the patient. Patients from the initial study have had very encouraging results. The expanded study will begin in February 1995.

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