United Press International - Wednesday, February 03, 1999
Ed Susman

Only patients whose bodies are able to suppress the virus in blood to undetectable levels for more than a year are being enrolled in the study, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said today.

Fauci said the trial started four weeks ago and involves about a dozen patients. "We will enroll 50 patients in the study," he said. "They will be randomized to either stay on their drug regimen or to stop drugs."

Fauci cautioned that the results of the trial will not be known for at least a year. The first patients who discontinued medication in the trial have shown no signs of the virus rebound, Fauci said, but those tests were only done a couple of weeks after the patients left therapy.

Late last year Fauci said a protocol had been prepared to study what happens if patients who have been successful in suppressing the virus below levels of detection for a long period decide to quit treatment.

At that time, Fauci said he believed the virus would come back.

Dr. Bruce Walker of Massachusetts General Hospital and Harvard School of Medicine, Boston, said at the conference he had a patient who stopped medication after 17 months of suppression of virus, but the virus rebounded within three months.

Doctors are concerned that if the virus rebounds, it will return resistant to antiretroviral treatment, making future therapy difficult. In effect, they said, patients are gambling with their lives that they can continue to keep the virus suppressed.

Dr. Tae-Wook Chun, an HIV researcher at NIAID, said at the 6th Conference on Retroviruses and Opportunistic Infections, that two of the patients in the discontinuation trial were subjects whose blood was found free of the virus after scrutinizing more than 360 million cells. That data was presented last year at a meeting of the Infectious Diseases Society of America, and was repeated by Chun at the Chicago meeting.

Chun said the attempt to find virus in these two patients represented the "first evidence of failure to identify" virus in an HIV-infected individual.

The patients in the study were taking a multi-drug cocktail of anti- HIV drugs and also were receiving an immune system enhancer, Interleukin-2. Chun said patients in the study who didn't take IL-2 still had virus cells that could be found in sophisticated tests.

Fauci told United Press International: "In order to be eligible for the study, a patient must have had the virus suppressed to below 500 copies per milliliter for at least a year. Then that patient will have to undergo three consecutive tests in our laboratory to show that the virus is undetectable below the 50-copy level. The tests would be performed over several weeks. Then the patient will be randomized to either ending treatment or continuing it."

He said, "The two patients in the earlier study wanted to get off therapy." Fauci said the patients would be studied every other week, then once a month and then every two months if they continued to show no virus rebound.

Doctors cautioned patients against stopping therapy without careful discussion with their physician of the consequences. Dr. Franco Lori of Georgetown University who is studying the use of intermittent therapy with another immune modulator, hydroxyurea, said none of these early studies should be interpreted that it is safe for patients to discontinue treatment on their own. "Just don't do it," Lori said.

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