A Preliminary Study of Ritonavir, an Inhibitor of HIV-1 Protease, to Treat HIV-1 Infection

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

A Preliminary Study of Ritonavir, an Inhibitor of HIV-1 Protease, to Treat HIV-1 Infection

New England Journal of Medicine (12/07/95) Vol. 333, No. 23, P. 1534
Markowitz, Martin; Saag, Michael; Powderly, William G.; et al.

Markowitz et al. conducted a study of the safety and efficacy of ritonavir, a potent inhibitor of HIV-1 protease in vitro, in 62 HIV-1-infected patients. The 12-week trial consisted of a four-week randomized, placebo-controlled, double-blinded stage which was followed by an eight-week dose-blinded phase. Among the 52 patients who completed the study, the most frequent side effects were diarrhea and nausea; reversible elevations in serum triglyceride and (gamma)- glutamyltransferase levels were the most common laboratory irregularities. Overall, ritonavir produced rapid antiviral effects, with a mean maximal reduction in HIV-1 RNA copies per milliliter of plasma between 0.86 and 1.18 log in the four treatment groups. This effect was partially maintained after treatment, with mean plasma-viremia reduction of 0.5 log, though a more sensitive HIV-1 RNA test found a mean 1.7-log reduction. Based on the significant reductions in plasma viremia as well as substantial increases in CD4 levels, the researchers concluded that ritonavir is both well-tolerated and a potent antiviral, and that further clinical trials are therefore justified.

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