AIDS Drug Test Shows ‘Serious Promise, Risk’

The organizer of an underground test using the highly touted AIDS drug Compound Q on Tuesday released preliminary results showing that the treatment holds “serious promise and serious risk,” and he acknowledged that a third patient in the controversial experiment had died.

Martin Delaney, co-founder of Project Inform, said in an interview that blood tests on 34 trial subjects suggest that the drug boosted levels of white blood cells that are key sentinels of the immune system--called T4 cells--while reducing the level of activity of the human immunodeficiency virus. Data on 37 other trial subjects has not yet been compiled.

“This is not the home run that some people had hoped for,” Delaney said. But, citing what he called “the drug’s positive biological activity,” Delaney urged accelerated research on the drug.

Officials of the U.S. Food and Drug Administration said they had not seen Delaney’s data and therefore would not comment on his results. In July, the agency asked him to stop administering the drug and it is continuing to investigate Delaney’s program.

Delaney said he expected to meet with FDA officials next month to present his data. In an interview with The Times, FDA Commissioner Dr. Frank Young said the agency had “invited” Delaney to conduct an FDA-sanctioned trial through a community-based research organization.

Academic researchers, who have denounced Project Inform’s Compound Q tests since they were first made public in June, said the data was too sketchy to draw conclusions. And, like Delaney, they strongly cautioned desperate AIDS patients against self-experimentation with the drug.

“There is really nothing one can say at this point, except to people who have this drug in their refrigerators or have access to it through underground sources: Please do not take it,” said Dr. Mathilde Krim, founding chair of the American Foundation for AIDS Research.

Despite an import alert established by the FDA in July, between 500 and 1,000 doses of the drug are believed to have slipped into the United States from China. Compound Q is a purified form of trichosanthin isolated from the root tubers of a cucumber plant known as Trichosanthes kirilowii.

Researchers at UC San Francisco and San Francisco General Hospital have been conducting FDA-sanctioned trials to determine the toxicity and maximum tolerable dose of the official version of the drug, known as GLQ-223, since May 15. Official of Genelabs Inc., makers of GLQ-223, declined comment.

There have been no deaths in the official trial, though sources said that one of 18 patients enrolled in the experiment lapsed into a coma last month but has since recovered.

Project Inform’s test, conducted by doctors in San Francisco, New York, Los Angeles and Miami, was performed without oversight from an independent committee to look after the interests of experimental subjects.

“That was the big missing ingredient in the (Project Inform) trial,” said Krim, a former researcher at Memorial Sloan Kettering Hospital in New York. “There needed to be an impartial group of people who reviewed the data, interpreted the data, and reported them. One cannot take the word of a lay person.”

Stung by the criticism, Delaney said Tuesday he would assemble “a blue-ribbon panel” to examine the data and to investigate the latest death, which occurred last month in New York.

The two earlier deaths were in San Francisco. The first patient died after asking doctors to terminate life-support measures when the drug failed to clear up Kaposi’s sarcoma lesions in his lungs; the second lapsed into a coma and later died.

The deaths have caused a deep schism among AIDS advocates, some of whom have joined academic researchers in sharply criticizing Delaney. “All studies, official or unofficial, need to live up to the highest standards of scientific inquiry and medical care,” said Mark Harrington, a member of the Treatment and Data Committee of the AIDS Coalition to Unleash Power.

Harrington, like Delaney, has been a frequent critic of the pace and priorities of federal and academic research effort on AIDS.

“Even if this drug is active, we still do not know how to use it, how often, in what dose, and in what combinations with other drugs,” he added.

Delaney presented data from only the San Francisco and New York arms of the trial because of what he termed “record-keeping problems” in Los Angeles and Miami. As in the past, he played down the latest patient death, noting that it took place six weeks after the drug was taken and suggesting that it could have resulted from the patient’s underlying illness.

In San Francisco, the average patient showed a 12% increase in T4 cells to 102 per cubic millimeter of blood after two months of three weekly applications of the drug. In New York, where the average patient was a bit healthier, the jump in T4 cells was a more robust 42%, to 169. Healthy people usually have T4 counts of more than 800.

Delaney also reported that nine of 15 patients in San Francisco showed “sustained reductions in P-24 antigen levels averaging 50%.” The P-24 test is a measure of viral activity, although its usefulness in evaluating AIDS drugs is the subject of considerable debate.

Separately, a study released by UC San Francisco doctors at a medical conference in Houston showed that 28% of AIDS patients in that city are taking unapproved medications, often without telling their doctors.

Study author Dr. Ruth Greenblatt said such self-medication poses risks of potentially fatal drug interactions.

Times medical writer Robert Steinbrook contributed to this story from Los Angeles.