CHAPEL HILL, N.C. -- The National Institute of Allergy and Infectious Diseases has stopped an AIDS drug clinical trial early because researchers have found a three-drug "cocktail" including the protease inhibitor indinavir significantly reduced AIDS symptoms and prolonged patient survival compared to a combination of two drugs.
Known as AIDS Clinical Trials Group (ACTG) 320, the study was being conducted with 1,156 people at 40 sites across the nation. An independent National Institutes of Health monitoring and safety board, which had continuous access to patient information, recommended halting the study even before all patients were enrolled because results were so dramatic.
The University of North Carolina at Chapel Hill School of Medicine enrolled 97 patients, which was the most in the United States. UNC-CH was among four centers that completed a study last year showing that indinavir, when combined with zidovudine (ZDV) and lamivudine (3TC), both significantly reduced AIDS virus levels in patients and boosted levels of CD4 cells, the infection- fighting cells the virus attacks and slowly destroys.
Volunteers in ACTG 320, randomly assigned to different treatment groups, all had CD4 cell counts below 200 per cubic millimeter of blood when the study began, while a normal count is above 500 per cubic millimeter.
"This new study is the first clear demonstration that, as we expected, the three-drug cocktail actually improves survival among patients and reduces progression to AIDS," said Dr. Joseph Eron, assistant professor of medicine and associate director of UNC-CH's AIDS Clinical Trials Unit. "It is extremely comforting to know that this approach to treatment will offer patients clinical benefits. These very exciting results renew our enthusiasm for this approach, which now clearly is the best treatment we have available."
Others involved at UNC-CH include Dr. Charles van der Horst, associate professor of
Contact: David Williamson
University of North Carolina at Chapel Hill