AIDS Treatment News #162, November 6, 1992
John S. James
Volunteers must:
* be HIV positive;
* have KS but no evidence of pulmonary or gastrointestinal KS;
* be ambulatory and at least well enough to care for themselves; and
* be on a stable dose of antiretroviral therapy for at least a month.
Also, because the drug has caused small hemorrhages in animals at very high doses, this trial has strict exclusion criteria for hematological abnormalities, including hemoglobin less than 9, ANC less than 1,000, platelets less than 100,000, or APTT or PT greater than 120 percent of normal, or known bleeding disorders. Persons are also excluded if they have pulmonary KS, actively bleeding or critically located KS, or life-threatening KS which is responsive to other treatments. Other exclusions are grade 2 or greater peripheral neuropathy from any cause, seizures in the last 10 years, any cancer except completely removed basal cell carcinoma of the skin, active severe or life-threatening infection, or KS treatment in the last three weeks with chemotherapy, interferon, radiation, steroids, or any local KS treatment such as intralesional injections. There are other entry criteria, but the ones listed above are most likely to exclude potential volunteers. Because this is the first human trial of the drug, the entry criteria are strict both to reduce the danger to the volunteers and to allow the most scientific knowledge to be obtained; future trials will probably have less severe restrictions.
As this article goes to press, two volunteers are enrolled; as many as 48 will be recruited. The drug is given intravenously, during one hour, every other day. Eight dosage levels will be tested (from 4.6 to 76.3 mg per meter squared every other day), with three to six patients at each level, unless toxicity prevents the higher doses from being tried. The reason for the schedule with the two-week break is that new drugs are not usually tested in humans for longer than the animal toxicity trials have run, in this case four weeks; the FDA allowed a six-week test after the break, since there was no evidence of any cumulative toxicity in the animals.
Arrangements
Volunteers will probably need to stay near Washington, D. C. for most of the 12 weeks of the trial. (The 12 weeks includes a two-week rest period, after the first four weeks, during which volunteers from outside the Washington area can go home.) For the first two weeks of receiving the drug, each volunteer will be an inpatient at the Clinical Center of the National Institute of Health, in order to allow careful medical monitoring. For the rest of the time, living expenses can be partially covered for those from outside the Washington area. Persons must pay their own expenses for traveling to NIH for the first time to be evaluated for this trial; after they are accepted as NIH patients, NIH will pay transportation to and from home, in addition to the living expenses.
For information about volunteering for this trial, call Sergio Bauza, R. N., or Kathleen Wyvill, R. N., at the National Cancer Institute, 301/496-8959, or James Pluda, M. D., 301/496-8398.
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