Important note: Information in this article was accurate in 1989. The state of the art may have changed since the publication date.
Study indicates compound Q fights AIDS but isn't a cure
San Francisco Chronicle - Friday, September 8, 1989
Randy Shilts, National Correspondent
Preliminary results from the underground trial of Compound Q have found that the drug may prove to be a significant weapon against the AIDS virus but that it is not the cure some had hoped it would be, according to a San Francisco doctor working on the study. Dr. Larry Waites, one of the key physicians conducting the Compound Q study, said virtually all of the 14 Bay Area men treated with the drug showed evidence of dramatic decreases in activity of the human immunodeficiency virus. About half the participants also showed increases in the level of T-4 lymphocytes, the crucial immunological blood cells whose destruction by HIV presages the onslaught of deadly AIDS-related diseases, he said. Immunological improvements were most pronounced in men who were healthier at the time they were injected with the drug, a purified derivative of a Chinese herb. "We have evidence of decreased viral activity. This is an incredible leap forward," Waites said. However, he added, "We are convinced now that it's not that three shots are a cure, as we had hoped." Instead, he said, Compound Q may eventually be used with a regimen of other drugs, such as AZT, to provide long-term control of HIV infection, similar to the way in which insulin is used to manage diabetes. REPORT WITHIN 2 WEEKS Definitive results from more than 40 patients participating in the nationwide underground trial will be tabulated and released within two weeks at a community meeting in San Francisco, said Martin Delaney, co-director of Project Inform, the AIDS information and lobbying group that organized the study. At the same time, Delaney said, Project Inform will present its data to the Food and Drug Administration. "The only thing that counts is the legitimate statistical analysis of the data, and we don't have that completed yet," Delaney said yesterday. "There's the likelihood that this drug will play a role in the chemotherapy of AIDS, but we still have a big learning curve ahead of us about how to use this best." News of the clandestine Project Inform trial rocked the medical world 10 weeks ago because the research was being conducted outside the normal channels of scientific research and government regulatory bodies. Despite its unorthodox setting, results from the study are being eagerly awaited by researchers throughout the United States because of the optimism over Compound Q. Earlier research by scientists at the University of California at San Francisco found that GLQ-223, as the drug is officially known, appeared to kill HIV-infected immune cells selectively in the test tube. If the drug performed that feat in HIV-infected people, researchers believed that they might have a substance that could be tantamount to a cure. UNAPPROVED STUDY Given the euphoria about Q's potential and worried about delays in established research channels, Project Inform and physicians in Miami, New York, Los Angeles and San Francisco organized their unapproved study, in which doctors monitored patients who decided to take the drug, smuggled into the United States from China. Waites, one of the most outspoken doctors participating in the trial, said patients have shown a decrease in levels of the p24 antigen, a viral protein whose presence in the blood is believed to reflect HIV activity. Although the p24 levels tend to rise again weeks after infusion of Q, they do not return to levels as high as the patients had before treatment, he said. Immunological improvements were pronounced in patients who had between 100 and 300 T-4 lymphocytes per cubic millimeter of blood at the start of the Q infusions, Waites said. Robert Pitman, a San Francisco playwright who was part of the underground trial, said that he had not expected Compound Q to be "a magic bullet to stop AIDS" and that he was pleased with the benefits he had experienced from his three infusions with the drug. "It's absolutely a net gain," said Pitman, who took his first shot of Compound Q in late May. "My appetite and energy level has improved. Before this, I had to sleep 14 hours a day. Now I'm back to eight hours -- or nine hours if I really indulge myself." The level of p24 antigen in his blood had dropped from more than 500 at the start of the study to 88 after his first infusion and has risen to only about 110 now, Pitman said. "I'm looking forward to a reinfusion when that's possible," he said. At the request of the FDA, the study organizers said they would not administer the drug further until the trial results had been reviewed by the FDA. A smaller, government-approved trial of GLQ-223 is being conducted at San Francisco General Hospital. A hospital spokesman said yesterday that researchers there declined to comment on either the progress of their official trial or the initial results from the unofficial research. An FDA spokesman said yesterday that an agency investigation of the Project Inform trial "is still on-going."
Keywords: AIDS; MEDICINE; DRUGS; RESEARCH; TESTS; SECRECY; REPORT; SF; COMPOUND Q (DRUG); GLQ-223 (DRUG); LARRY WAITES; PROJECT INFORM; MARTIN DELANEY
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