AIDS Treatment News #186 - November 5, 1993
But it is not yet known if this T-helper increase is clinically helpful. And IL-2 treatment can cause a number of side effects -- including increasing the growth of HIV. Therefore, before this treatment becomes widely used, more needs to be learned about whether it is helpful, and how to use it best.
A small trial now starting in San Francisco will test IL-2, mainly to see whether subcutaneous dosing is feasible (IL-2 is usually given intravenously). The drug is poorly absorbed subcutaneously, and can cause local reactions at the injection site. After learning what dose is tolerable, the study will test that dose on additional patients to see if it is biologically active in affecting blood test results. The doses used in this study will vary between 3 million and 18 million international units; the dose assigned to each patient will remain the same throughout the study.
This trial will give IL-2 on days one through five, and days eight through twelve, of a 28-day cycle; the trial will last for 13 cycles. After the first cycle, volunteers will be taught to give their own injections, so they will need only two clinic visits per month (for testing, and to pick up a new supply of the drug).
To qualify for this study, volunteers must have T-helper counts from 200 to 500, and not have had any AIDS-defining opportunistic infection. They must have been on an approved antiretroviral drug (AZT, ddI, or ddC) for at least two months before the trial, and need to stay on antiretroviral therapy during the trial and for at least two months after. Mucocutaneous KS, and local KS treatment, are OK. There are certain other medical inclusion/exclusion conditions.
For more information about this trial, contact Stephanie La Carrubba, R.N., 415/565-6524.
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