A Short-Term Study of the Safety, Pharmacokinetics, and Efficacy of Ritonavir, an Inhibitor of HIV-1 Protease

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

A Short-Term Study of the Safety, Pharmacokinetics, and Efficacy of Ritonavir, an Inhibitor of HIV-1 Protease

New England Journal of Medicine (12/07/95) Vol. 333, No. 23, P. 1528
Danner, Sven A.; Carr, Andrew; Leonard, John M; et al.

A double-blind, randomized, placebo-controlled Phase I and II study of 84 HIV-infected individuals with CD4 levels greater than 50 revealed that the HIV-1 protease inhibitor ritonavir was well-tolerated and had potent anti-HIV activity. Danner et al. report that during the initial four weeks of the study, which was supported by Abbott Laboratories, the four different ritonavir dosage groups had similar increases in CD4 counts and reductions in the log number of copies of HIV-1 RNA per milliliter of plasma. The three lower dosage groups, however, returned to base lines after 16 weeks. At the 32-week mark, the seven patients receiving the highest dosages had an average 230-cell increase in their CD4 levels, and an average 0.81-log reduction in the plasma concentration of HIV-1 RNA. Side effects included nausea, circumoral paresthesia, and elevated levels of hepatic enzymes. The researchers concluded that these early results with ritonavir monotherapy indicate high levels of antiviral and immunostimulatory activity, though further studies are required to determine ritonavir's efficacy in combination with other drugs.

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