San Francisco Chronicle - Friday, July 28, 1989
David Perlman, Chronicle Science Editor

Volunteer patients undergoing an important human trial of the experimental AIDS drug known as DDI have shown strong improvement in the most important symptoms of their disease after nearly 10 months of treatment, scientists at the National Cancer Institute reported yesterday.

Because of the drug's early promise, Dr. Paul Volberding, chief of AIDS services at San Francisco General Hospital, said yesterday that he and colleagues in Boston and New York will begin leading a far larger series of DDI trials that will start enrolling scores of patients at 40 medical centers around the country by September.

DDI, whose technical name is dideoxycytidine, attacks the AIDS virus by impairing its ability to reproduce in much the same way as does AZT, the only anti-viral compound that is fully approved by the Food and Drug Administration.

But the newer drug appears to be far less toxic than AZT and has also been given successfully to AIDS patients who cannot tolerate the already approved drug, the cancer institute researchers said.

The first report of the trial results is being published today in the journal Science by a team of 10 specialists headed by Dr. Robert Yarchoan and Dr. Samuel Broder, who have been in the forefront of the AIDS battle since the earliest days of the 8-year-old epidemic.

"This is not a cure for AIDS," Yarchoan told reporters, "but it appears to control the disease. It can keep the virus from replicating, but it can't rid the body of the virus."

Volberding said that he and his research colleagues, who organized the nationwide AIDS Clinical Trials Group, hope to get expanded trials of DDI going at "a very fast pace," noting that the group expects swift approval from the FDA and strong cooperation from the drug's manufacturer, the Bristol-Myers Co.

The expanded trials will compare the drug's effectiveness with that of AZT in some patients and will also test it in other patients who cannot tolerate even small amounts of AZT, Volberding said.

The current trial series at the cancer institute has involved 25 men and one woman who have received DDI in various amounts for as long as 42 weeks.

In their report, the researchers said they have seen major evidence of improvement in the immune systems of the patients - indicated by a significant increase in their critically important T-4 cells - and an 80 percent decrease in the antigens that mark the presence of HIV, the human immunodeficiency virus that causes AIDS. All patients, including those who received relatively infrequent doses of the drug, gained weight, and their general health appeared to improve as well, the report said.

Although the trial at the cancer institute cannot demonstrate the drug's ultimate usefulness in curbing the disease or in forestalling death from AIDS, the results so far "are predictive of prolonged survival and reduced incidence of opportunistic infections," Yarchoan and Broder wrote.

Four other small-scale trials of the drug are now under way, but all - including the trial of Yarchoan and Broder - are in only their first phase under FDA rules. These "phase one" trials are supposed to test only the safety of the drug in various doses, but DDI's apparent effectiveness has spurred the move toward rapid expansion of the drug tests into what the FDA terms "phase two" trials.

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