In the July 14 issue of The Journal of the American Medical Association (JAMA), researchers from Johns Hopkins and other institutions will present results from what is believed to be the first three-year, randomized, double-blind, clinical trial comparing antiretroviral therapies for HIV infection.
Their findings, to be made public July 11 at a JAMA media briefing, show that combination regimens including tenofovir DF (Viread) or stavudine (d4T, Zerit) are equally effective, but tenofovir DF has less toxic outcomes with respect to cholesterol levels, lipodystrophy (changes in distribution of body fat) and peripheral neuropathy (pain or numbness in legs.)
The study involved more than 600 patients in 81 centers in the United States, South America and Europe, and was conducted from July 2000 to January 2004.
"These results support the use of tenofovir DF as a component of initial therapy for HIV infection," says study lead author Joel Gallant, M.D., M.P.H., assistant professor and associate director of the AIDS Service at The Johns Hopkins University School of Medicine.
Comparing the Efficacy and Safety of Tenofovir DF vs. Stavudine in Combination Therapy in Antiretroviral-Naïve Patients. Joel E. Gallant, Schlomo Staszewski, Anton L. Pozniak, Edwin DeJesus, Jamal M.A.H. Suleiman, Michael D. Miller, Dion F. Coakley, Biao Lu, John J. Toole, Andrew K. Cheng,. (JAMA. 2004; 292:191-201. Available post-embargo at JAMA.com)