Interleukin-2 Improves CD4 Counts In Patients With AIDS
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Interleukin-2 Improves CD4 Counts In Patients With AIDS

CHICAGO, IL -- June 22, 1998 -- Results of a new study show interleukin-2 (IL-2) therapy significantly increases CD4 cell counts and other key immune markers in patients with AIDS without increasing their HIV viral levels. These results will be presented by Daniel Berger, M.D. at the upcoming 12th World AIDS Conference in Geneva, Switzerland on July 1, 1998.

The study also shows that treatment with IL-2 was safe and tolerated by patients with advanced HIV on stable antiretroviral therapy.

"Our findings demonstrate that IL-2 therapy is a viable option for people with AIDS," said Berger, M.D., medical director of NorthStar Medical Center in Chicago, IL. "While it was previously believed that IL-2 therapy had limited benefit for patients with advanced HIV, we have found that IL-2 induces significant immune recovery in this population."

IL-2 is a natural cytokine produced by the human body in response to viral infection. Chiron Therapeutics currently markets a recombinant version, called Proleukin(R), to treat certain forms of kidney cancer. Studies published in the New England Journal of Medicine have concluded that IL-2 significantly raises CD4 cell counts in patients with early-to-moderate stage HIV infection. However, the role of IL-2 in patients with late-stage disease has not been clearly defined.

The study examined 15 patients with AIDS who were on stable protease inhibitor-containing regimens. Patients were subsequently placed on IL-2 therapy with dosages ranging from nine to 18 million units once daily for five days in cycles delivered approximately every eight weeks. The results showed that IL-2 therapy significantly increased absolute CD4 counts, CD4 percentages, as well as naive (CD45+RA) and memory (CD45+RO+) cells. The results also revealed no statistically significant increase in HIV RNA levels after long-term therapy with IL-2.

The most common clinical side effects of IL-2 therapy included fever, chills, fatigue, malaise, sinus congestion, headache and nausea. Generally, fever was the most severe side effect, with temperatures rising to 103 degrees. Side effects were managed with symptomatic treatment. Side effects tended to be most severe on the fourth and fifth day of cycles, but generally resolved within 24 hours after therapy.

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