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Previous Volume 333:1528-1534 December 7, 1995 Number 23 Next

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ABSTRACT

Background Reverse-transcriptase inhibitors have only moderate clinical efficacy against the human immunodeficiency virus type 1 (HIV-1). Ritonavir is an inhibitor of HIV-1 protease with potent in vitro anti-HIV properties and good oral bioavailability.

Methods We evaluated the antiviral activity and safety of ritonavir in a double-blind, randomized, placebo-controlled phase 1 and 2 study of 84 HIV-positive patients with 50 or more CD4+ lymphocytes per cubic millimeter. The patients were randomly assigned to one of four regimens of ritonavir therapy, or to placebo for four weeks and then (by random assignment) to one of the ritonavir regimens.

Results During the first 4 weeks, increases in CD4+ lymphocyte counts and reductions in the log number of copies of HIV-1 RNA per milliliter of plasma were similar among the four dosage groups, but in the three lower-dosage groups there was a return to base-line levels by 16 weeks. After 32 weeks, in the seven patients in the highest-dosage group (600 mg of ritonavir every 12 hours), the median increase from base line in the CD4+ lymphocyte count was 230 cells per cubic millimeter, and the mean decrease in the plasma concentration of HIV-1 RNA (as measured by a branched-chain DNA assay) was 0.81 log (95 percent confidence interval, 0.40 to 1.22). In a subgroup of 17 patients in the two higher-dosage groups, RNA was also measured with an assay based on the polymerase chain reaction, and after eight weeks of treatment there was a mean maximal decrease in viral RNA of 1.94 log (95 percent confidence interval, 1.37 to 2.51). Adverse events included nausea, circumoral paresthesia, elevated hepatic aminotransferase levels, and elevated triglyceride levels. Ten withdrawals from the study were judged to be related to ritonavir treatment.

Conclusions In this short-term study, ritonavir was well tolerated and had potent activity against HIV-1, but its clinical benefits remain to be established.

Source Information

From the Academic Medical Center, Amsterdam (S.A.D., C.A.B.B.); St. Vincent's Hospital, Sydney, Australia (A.C., D.A.C.); Abbott Laboratories, Abbott Park, Ill. (J.M.L., L.M.L., A.H., J.M.V.); the Hospital de Bellvitge "Principes de España," Barcelona, Spain (F.G.); the Hospital La Paz, Madrid (J.G., A.G.A.); the Hospital Germans Trias i Pujol, Barcelona, Spain (A.R.); the Hospital 12 de Octubre, Madrid (R.R., R.D.); the Hospital General Gregorio Marañon, Madrid (E.B.); the Hospital Ramón y Cajal, Madrid (V.P.); the Hospital Clinico de Valencia, Valencia, Spain (J.G.L.); and the University Hospital Utrecht, Utrecht, the Netherlands (J.C.C.B.).

Address reprint requests to Dr. Danner at the Division of Infectious Diseases, Tropical Medicine, and AIDS, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.

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