San Francisco Chronicle - The Voice of the West, 901 Mission Street, San Francisco, CA 94119 - Thursday, October 31, 1996 - Page A4
David Perlman, Chronicle Science Editor

The protein, called interleukin-2, has resulted in "dramatic and sustained" improvements to the immune systems of 30 patients who received periodic infusions of the drug along with standard anti- viral medications, the government researchers say.

Their carefully controlled study of 60 patients -- half received the protein and half did not -- was a follow-up to an early report last year. The initial study provided encouraging evidence to the researchers' theory that interleukin-2 -- known as IL-2 -- might help improve the ability of AIDS- infected patients to fight the virus.

Now, the researchers say, they have already begun testing the effects of the protein in a group of patients being treated with one of the powerful new protease inhibitor drugs that are apparently capable of reducing the AIDS virus to undetectable levels in their bodies.

A report on the new study is being published today in the New England Journal of Medicine, by Dr. Joseph A. Kovacs and Dr. A. Clifford Lane of the National Institute of Allergy and Infectious Diseases.

But in an interview yesterday Dr. Anthony S. Fauci, the institute's director and the government's chief AIDS researcher, underscored his caution.

"I'm enthusiastic about the results," Fauci said, "but we haven't yet proven a clinical benefit in the patients, and I'll be much more enthusiastic when I see more than the promising laboratory results."

By "clinical benefit," Fauci meant proof that patients using IL-2 in conjunction with their anti- viral drugs are better able to resist developing the often-deadly infections that come with AIDS and were able to live far longer.

The primary infection-fighting white blood cells of the immune system are known as CD4 cells. The CD4 cell count in an undamaged immune system can range from 700 or 800 to more than 1,000 per cubic millimeter of blood.

In the study by Kovacs, Lane and their colleagues, half the 60 patients received IL-2 along with conventional anti-viral drugs such as AZT and related compounds, while the others received only the anti-virals. The patients in the IL-2 group saw their average CD4 cell counts rise from a dangerously low 428 to a normal 916 within a year, and the improvement has now continued for more than two years, the researchers report.

One of the most important new ways to determine the effectiveness of anti-viral therapy is to measure a patient's "viral load" -- the quantity of HIV, the virus that causes AIDS, that can be detected in the blood. As an AIDS infection progresses, the quantity of virus increases, and the more likely it is that infection will lead to outright disease.

As expected, IL-2 itself showed no effect on the viral load of the patients in the clinical trial, but the few patients who have begun receiving the protease inhibitor called indinavir have shown significant decreases in their viral loads, the researchers said.

Interleukin-2 is manufactured by the Chiron Corp. of Emeryville, and the company itself has been sponsoring a variety of clinical trials of its immune-boosting protein at several AIDS research centers in the United States, Australia and France.

More than 500 patients have been involved in those trials, said Dr. Gwendolyn Fyfe, Chiron's medical director, and the trends of all the studies are showing similar promising results. Fyfe is a member of the study team led by Kovacs and Lane.

Working with other medical centers and community physicians in the AIDS Clinical Trials Group known as ACTG, the researchers are developing strategies for much larger studies that will examine the combination of IL-2 and the powerful new protease inhibitor drugs. HIV-infected individuals and their physicians interested in the trials can telephone (800) AIDS- NIH for more information.
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