GAY PEOPLE'S CHRONICLE NOVEMBER 25, 1994

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HEALTH WATCH

Clinical trials unit is looking at immune-based therapies

by Michael M. Lederman, M.D.

As the mysteries of AIDS unravel more mysteries, immune-based therapeutic trials become an increasingly important part of the effort to understand and treat HIV infection.

First and perhaps most important, HIV infection is a disease of the immune system.

It is the depression of immune responses that is responsible for most of the infections that cause disease in people with AIDS. If we can restore immune responses in people with AIDS, infectious complications will be prevented.

Second, HIV is an infection of immune cells that uses the machinery of these cells as a factory to produce more virus. If we can target treatment strategies against this machinery, we may be able to block the growth of the virus. What's more, because the cell's machinery is controlled by the cell's genes, not the virus' genes, HIV has no way to develop a mutation to resist this kind of treatment.

Third, as we are learning more and more about the complications of AIDS, it appears that some of these complications, for example, decreased platelets, aphthous ulcers, kidney failure and arthritis, may be caused by immune cells or their products. Treatments that target immune cells or their products may correct some of these complications.

A number of immune-based therapeutic trials are going on in Cleveland or will begin shortly. We are now testing a new drug called Tenidap that blocks production of tumor necrosis factor (TNF) and another cytokine called IL-6. Both TNF and IL-6 are proteins made in the body that speed the growth of HIV.

In two different trials, we are examining the effects of thalidomide-a drug that blocks TNF as a treatment for aphthous ulcers and as an antiviral immunomodulator in people with HIV. [Readers may remember thalidomide as the drug that caused a rash of birth defects in Europe in the late 1950s after

it was prescribed to pregnant women for morning sickness.]

We will soon examine the role of prednisone as an immunomodulator, and as a treatment for kidney failure in AIDS.

We are about to study the effect of pentoxifylline, another TNF inhibitor as an additional treatment for people with HIV infection and tuberculosis. In a few months, we will be testing interleukin-2 (IL-2), a protein that is deficient in AIDS. IL-2 is a helper molecule that helps T cells work and increases the number of T-helper cells in the circulation. Other trials are in development and will begin in 1995.

Finally, immune-based therapy trials can also help us learn more about HIV. In an important way, these studies may be the only way to learn for sure if theories about HIV that are generated as a result of basic laboratory research are correct.

For example, there is a great deal of interest in the role of oxidative stress in AIDS. Blood levels of the antioxidant glutathione are depressed in people with HIV and in the test tube, a number of antioxidants can block the growth of HIV. We have just completed a multicenter trial of the antioxidant procysteine. If this agent proves to be of some value, this information is important from a therapeutic perspective but just as important, a positive result would support the idea that oxidative stress is important in AIDS.

The more we learn about HIV, the better our chances of finding a truly effective and long lasting treatment for it.

Over the next few months, the doctors from our AIDS Clinical Trials Unit will keep you updated on HIV treatment news. For more information about HIV treatment trials in Cleveland, call 216-368-2437.

Dr. Lederman is principal investigator of the AIDS Clinical Trials Unit at University Hospitals of Cleveland. He is also chairman of the General Immune Modulation Working Group of the national AIDS Clinical Trials Group.

Gay men's brains are different

Continued from Page 1

said its results and implications apply only to groups and not individuals.

Witelson, a psychiatry professor at McMaster University in Hamilton, Ontario, discussed the work before presenting it November 17 in Miami Beach, Fla., at the annual meeting of the Society for Neuroscience.

Studies in 1991 and 1992 reported size differences elsewhere in the brain that were related to sexual orientation. Other studies have found possible genetic factors in determining sexual orientation.

"Witelson's study is an important addition to the growing body of evidence indicating a biological basis for homosexuality in some people," Peri Jude Radecic, executive director of the National Gay and Lesbian Task Force, said in a statement. "And it shows that homosexuality is a naturally occurring and common variation among humansa fact that gay and lesbian people have known all along."

Roger Gorski, co-author of the 1992 study on brain differences between gay and heterosexual men, said the discovery of another difference is no surprise. "I'm sure we're going to find others," he said in a telephone interview.

But it's not clear whether the brain differences found so far really influence sexual orientation, and they may even be results of it, he said. Nor is it clear whether the brain differences affect mental functioning, he said. Gorski, a professor of anatomy and cell biology at the medical school at the University of California at Los Angeles, also said

the size differences in Witelson's study might have been due simply to chance.

Scientists are debating what produces sexual orientation. Witelson said the idea that biology plays a role "clearly does not mean that environment is irrelevant, but what it means is that environment is not the whole story."

Witelson and colleagues at her university and the University of Toronto's Sunnybrook Health Science Centre scanned brains in 11 gay men and 10 heterosexual men. The men were matched for age, and all said they were free of disease.

Researchers focused on a structure called the isthmus of the corpus callosum. The isthmus runs between the right and left sides of the brain, lying roughly between the ears.

Brain scanning showed that on average, the isthmus was 13 percent thicker in the gay men than the heterosexual men. But some of the gay men had a thinner isthmus than some of the heterosexual men, so an individual's isthmus size cannot reveal his sexual orientation, Witelson said.

"Studies of human sexuality are not conducted in political and social vacuums," Radecic noted, "The results must therefore be used in the most ethical ways and precautions must be taken to ensure that the studies are not used against any individuals or groups."

"This is especially true to avoid potential genetic engineering if science should ever discover a gene responsible for homosexuality," she continued.