7th Conference on Retroviruses and Opportunistic Infections
 


Anti-HIV Activity and Tolerability of DAPD, a Novel Dioxolane Guanosine RT Inhibitor: Initial Results of a Phase I/II 14-Day Monotherapy Clinical Trial

D. D. RICHMAN*1, H. KESSLER2, J. ERON3, M. THOMPSON4, F. RAFFI5, J. JACOBSON6, J. HARRIS7, B. MCCREEDY7, J. BIGLEY7, and F. ROUSSEAU7. 1Univ. of California, San Diego; 2Chicago Ctr. for Clin. Res., IL; 3, Univ. of North Carolina at Chapel Hill; 4AIDS Res. Consortium of Atlanta, GA; 5Hotel Dieu-CHU, Nantes, France; 6Mt. Sinai Med. Ctr., New York, NY; and 7Triangle Pharm., Durham, NC

DAPD is a novel nucleoside analog that is deaminated by ADA to DXG producing in vitro activity against strains of HIV resistant to drugs such as ZDV, 3TC, & abacavir. Preliminary results of a non-randomized, Phase I/II trial in antiretroviral-naïve HIV (+) volunteers are:

No changes in HIV RT-genotypes have been observed on treatment in the first 18 subjects tested. All doses of DAPD have been very well tolerated to date. These initial results demonstrate dose-related antiviral activity of DAPD against HIV in humans, suggesting potent activity and a promising tolerability profile. This trial is ongoing and further work is warranted at higher doses and in different patient populations.

Key Words: anti-HIV clinical trials, DAPD, novel nucleosides

 

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