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New Drugs in Multinational Study Show Promise in Fighting,Drug-Resistant HIV

Phase III clinical trial provides hope that HIV patients can live longer lives

PASADENA, Calif., July 05, 2007 /PRNewswire/ -- A new investigational drug used in combination with a second newer agent has proven to be effective in fighting drug-resistant HIV, according to a Lancet article to be published in its July 7th special HIV/AIDS issue.

The multinational phase III clinical trial, which involved 18 nations and more than 30 centers in the United States, is the first trial to offer patients infected with resistant HIV the potential of receiving two investigational new drugs together to fight the disease. The two drugs, amongst the most powerful agents to fight the disease to date, are TMC125 (etravirine) and TMC114 (darunavir, also known as Prezista), both made by Tibotec (a Johnson & Johnson company), the sponsor of the ongoing trial. The data will be presented for the first time during the July 22nd-25th International AIDS Society conference in Sydney, Australia by the lead investigator in the trial, Dr. Adriano Lazzarin of Italy.

"This study is one of the most significant worldwide HIV/AIDS clinical trials in recent years. It showed that when the two drugs are used in combination, there is a good chance HIV can be very effectively controlled in patients who have advanced, multi-drug-resistant HIV," said William J. Towner, MD, Kaiser Permanente Southern California, a co-author of the Lancet article. Kaiser Permanente had the highest number of enrollees in the study from the United States.

Dr. Towner said that the ongoing 'DUET-2' trial -- large, randomized, and placebo controlled -- is the pivotal registration and efficacy trial for TMC125 (it is in a class of HIV drugs called non-nucleoside reverse transcriptase inhibitors [NNRTI]). The Lancet study found that at the 24th week, patients who received TMC125 in combination with TMC114 achieved superior virological suppression than t
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