United Press International - Thursday, February 04, 1999
Ed Susman

At the 6th Conference on Retroviruses and Opportunistic Infections, researchers said today the key to the Berlin patient's condition could be initial treatments with hydroxyurea, a 40-year-old anticancer drug that seems to play a role in immune system modulation.

The Berlin patient, a 29-year-old homosexual man, was treated after early infection with HIV, said Dr. Franco Lori of the Research Institute for Genetic and Human Therapy at Georgetown University in Washington, D. C.

Lori said the Berlin patient was treated with hydroxyurea, and two drugs from different classes of anti-AIDS drugs, a nucleoside analog didanosine (ddI) and a protease inhibitor indinavir.

With that treatment regimen, the amount of HIV circulating in the patient's blood dipped below the level of detection.

Lori said the patient unilaterally suspended treatment for a week shortly after he started therapy, and the virus reappeared. He took medication again for about three months and then quit for two weeks and the virus rebounded a second time.

Back on the medicine, the virus again fell below levels of detection. Another 40 days later, the patient stopped treatment. "Remarkably," Lori said, "There has been no virus rebound for more than two years."

An exhaustive search of blood cells was able to detect viable HIV at the rate of one viral copy in 44 million cells. This extremely low level of virus has remained constant.

Lori, in his own experiments with monkeys, infected the animals with a disease strain similar to HIV. Using intermittent therapy he was able to keep the virus level in the monkeys at very low levels.

He has now repeated the experiment with three HIV-infected men. The patients were treated with hydroxyurea, ddI, another nucleoside analog stavudine (d4T) and indinavir.

The patients took the drugs for three weeks, then were taken off medication for a week; re-started on medication for three months followed by halt in medication until a viral rebound occurs. The patients are now free of medication for eight weeks without a rebound.

"At first we thought the Berlin patient was unique," Lori said, "but now, we have increasing evidence of the possibility of control of HIV through intermittent therapy with hydroxyurea-based combinations."

However, Lori warns against patients trying the therapy on their own. "Just don't do it," he said. Lori said the experiments are still preliminary and if the virus rebounds it may be resistant and far more difficult to treat.

Another researcher using hydroxyurea in his work, Dr. Ian Frank of the University of Pennsylvania, Philadelphia, said, "It is obvious that we aren't going to beat AIDS unless we start thinking outside the box that says the only way to treat HIV is through suppression of the virus."

Frank said all the potent drugs used to fight HIV infection can create resistant virus. He said he believes that use of hydroxyurea will give patients a chance to control HIV, if not totally suppress it. And the control can be maintained without handfuls of pills several times a day.

Frank and Lori suggested that incomplete viral suppression may, paradoxically, help the patient's immune system by providing an immune target in the lingering virus.

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