"I hesitate to use the world miraculous," said Jacob Lalezari of Quest Clinical Research, who led one of two late-stage clinical studies of the drug, "but it's wonderful."
The drug, known as T-20, prevents the human immunodeficiency virus from infecting cells, and Lalezari said data from the clinical trials -- released for the first time -- show it works effectively in patients for whom other types of drugs no longer work well.
All the patients in the clinical study had developed resistance to all three types of anti-HIV drugs now on the market, he said, and many had developed full-blown AIDS. "These people are sick," Lalezari told United Press International. He said the new drug is "one of the most exciting things to happen since the protease inhibitors" -- a class of drugs introduced in the mid-1990s and credited with extending the lives of thousands of people infected with HIV.
Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, called T-20 an "important advance. We have been looking for some time for alternative targets" for new anti-HIV drugs. However, Fauci would not compare the drug's potential impact to the effect protease inhibitors had on the disease. Instead, he said only that T-20 "will potentially give hope to those individuals" who have developed resistance to current drugs.
HIV "shatters all your hopes and dream," said James Locke of London, a patient in the clinical trial. Now, he said, "I can actually dream again."
Locke said when he started on the new drug his blood had high levels of HIV and his immune system was almost completely destroyed. Now, he said, his virus is undetectable, and his immune system is almost back to normal levels.
"It was really quite remarkable," he said.
T-20 is what researchers call a fusion inhibitor, meaning it prevents the virus from binding to its target cells. Other anti-HIV drugs try to prevent the virus from growing once it has infected a target cell.
Dani Bolognese, of Trimeris Research in Durham, N.C., which developed the drug, told reporters, "the virus is basically frozen on the surface of the cell, can't enter the cell, and therefore cannot propagate in an HIV-infected person."
In the clinical studies, carried out in North America, Brazil, Europe and Australia, about 1,000 patients were given "optimized" treatment -- the best available current drugs for each patient. About two-thirds, chosen at random, also were given T-20.
Patients given T-20, Lalezari said, were twice as likely to show improvements in their infection levels and their immune system as those who received a cocktail of other drugs.