AIDS Drug Fares Well in Big Trial

T-20 -- the most advanced of a class of drugs known as entry inhibitors -- has proved to be effective in its initial large phase III clinical trial, opening a new front in the battle against AIDS, the drug's developers and doctors said Thursday. Entry inhibitors, also called fusion inhibitors, block HIV from infecting the cells of the immune system. Current drugs block one of the two enzymes that are used by HIV to replicate after it infects the immune system. Trimeris and Roche, the developers, said they would apply for approval of the drug early in the second half of this year. That could allow the drug to reach the market next year, analysts said.

Drugs in current use can suppress the virus, but drug resistance is common. So there is a need for drugs that work through different mechanisms to treat patients who are no longer helped by current drugs. "What we really need are drugs that act against different steps in the virus's life cycle," said Dr. Daniel R. Kuritzkes, an associate professor at the University of Colorado Health Sciences Center and one investigator in the clinical trial. Experts said the drug would mainly be used to help patients who have stopped responding to other drugs. T-20 has to be injected twice a day, while other AIDS drugs are taken orally.

Those who received T-20 along with some of the current drugs experienced a 98 percent decrease in virus levels in their blood after 24 weeks, compared with a median reduction of about 80 percent for the patients who received only the current drugs, said Dr. Dani P. Bolognesi, chief executive of Trimeris. Such a difference would mean that patients might live longer and maintain stronger immune systems, said Kuritzkes, who is an advisor to Roche and Trimeris. Results from a second phase III trial are expected in a few weeks, the companies said.

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