Experimental AIDS Drug to Be Given to Half of Patients

As many as 6,000 AIDS patients--about half of those afflicted in this country--will be offered an experimental drug that researchers believe may prolong their lives, federal health officials announced Friday.

If test results on the drug continue to be encouraging, they said, azidothymidine, or AZT, could be commercially available by prescription as early as January.

“I have charged the Food and Drug Administration to expedite the process whereby this drug is made available. . . “ said Dr. Robert E. Windom, assistant secretary for health. “We will move as quickly as possible.”

‘Important Step Forward’

Windom, speaking at a press conference, added: “Today’s announcement represents an important step forward in the search for an effective therapy for treating persons infected with the AIDS virus--but it is only one step.”

Initially, AZT will be given only to those AIDS patients who have suffered their first bout of Pneumocystis carinii pneumonia, a common AIDS symptom, within 90 days of applying for the drug, Department of Health and Human Services officials said. These were the same criteria required of participants in the study that prompted the decision to make the drug more widely available.

These qualifications may be expanded in coming weeks to make more patients eligible, according to department officials and representatives of the drug’s manufacturer, Burroughs Wellcome Co. of Research Triangle Park, N.C.

“There are additional criteria being developed right now that will be finalized over the next few days,” said Dr. David Barry, the company’s vice president for research.

Tests Include Six Drugs

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, estimated that 60% of the 11,000 to 12,000 AIDS patients in the United States would be eligible for the newly enlarged program. Thus far, only about 1,000 AIDS patients have been participating in studies of six different drugs in the United States.

The department also established a toll-free number, 800-843-9388, for inquiries from physicians and patients who are interested in applying for the drug.

Windom stressed that the drug “is not a cure for AIDS” and that researchers are uncertain of its long-term effects and how long the drug might prolong life.

AZT, also known as Compound S, will be dispensed upon the recommendation of a physician to those patients who meet the criteria and who are not currently participating in another clinical trial, Windom said. Physicians will be required to supervise administration of the drug and to file periodic reports to researchers, officials said.

Could Start in Two Weeks

The first patients participating in the widened study could receive the drug in less than two weeks, Fauci said.

Barry, from Burroughs Wellcome, said that the manufacturer will make the drug available free of charge, but added that it might take several months for the company to produce enough for the anticipated thousands of new patients.

The decision to make the drug more widely available came after an independent scientific board evaluated early test data on 282 patients, including both those suffering from AIDS or AIDS Related Complex, a milder form of the disease. Half of the patients were given the drug, while the remaining “control” group patients received a look-alike, harmless placebo.

There were 16 deaths among 137 patients receiving the placebo, and one death among 145 patients receiving AZT, a mortality difference that federal health officials and company representatives called “highly statistically significant.”

Helps ‘Quality of Life’

The board decided Thursday that the results justified making the drug available to those participants in the study who had been receiving placebos. Following the board’s recommendation, federal health officials decided to make the drug more widely available through an expanded study program.

Dr. Samuel Broder of the National Cancer Institute, who conducted the earliest human studies on AZT, said that 16 of his 19 patients are still living more than a year after beginning the drug. “I’d say there was a noticeable benefit in the quality of life,” he said.

Fauci said that without the drug an AIDS patient diagnosed with Pneumocystis carinii pneumonia lives an average of 35 to 40 weeks.

Has Side Effects

The drug, whose side effects include headache, nausea and anemia, works by playing a chemical trick on the virus that causes AIDS. Scientists believe it disrupts the chemical chain the virus needs to replicate itself inside the body of an AIDS patient.

AIDS, or acquired immune deficiency syndrome, destroys the body’s immune system, leaving it powerless against certain cancers, neurological disorders and otherwise rare infections. It is transmitted through intimate sexual contact--with the exchange of bodily fluids such as semen and blood--and through the sharing of unsterilized hypodermic needles.