NEW YORK (Reuters Health) - Results of a phase IIa clinical study indicates that the non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC125 is safe and effective in HIV patients, researchers report in the November 21st issue of AIDS.
Lead investigator Dr. Gerben van’t Klooster of Tibotec BVDA in Mechelen, Belgium, notes that his company has selected TMC125 for development because it retains its binding ability despite changes caused by common NNRTI resistance mutations. It also shows potent in vitro anti-HIV activity.
He and his colleagues conducted a double-blind trial involving 19 antiretroviral-naive HIV-1 infected subjects. They were randomized to monotherapy consisting of twice daily treatment with TMC125 900 mg or placebo.
At the end of the 7-day treatment period, there was a mean decrease in plasma HIV-1 RNA of 1.99 log10 copies/mL in the TMC group. In the placebo group, the drop was 0.06 log10 copies/mL.
There were comparable findings for plasma viral daily decay rates (0.33 log10 copies/mL versus 0.02 log10 copies/mL).
Three TMC-treated subjects reported somnolence, but most did not report any adverse events and no abnormalities were seen in factors including blood chemistry, results of urinalysis and vital signs.
The researchers thus conclude that the agent was well tolerated “and represents a promising and highly potent, next generation non-nucleoside reverse transcriptase inhibitor.”
Source: AIDS 2003;17:2487-2494. [ Google search on this article ]
MeSH Headings:Drugs, Investigational: Anti-HIV AgentsCopyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
