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To assess the clinical and economic consequences of the use of protease inhibitors in the treatment of HIV infection.Multicentric, observational, retrospective cohort study.Ten AIDS reference centres in France.All patients followed in each centre from September 1995 through October 1996.AIDS-defining events, death, health-care resources use, administration of antiretroviral therapy.Data from 7749 patients in 10 centres showed a drop in hospitalization days by 35%, new AIDS cases by 35%, and deaths by 46%. In the same period, the proportion of patients receiving antiretrovirals rose from 36 to 53% including highly active antiretroviral therapy (HAART), which rose from 0.3 to 18%. Overall cost evaluation showed a slight increase of monthly treatment cost of US$ 12 per patient. Comparison of the three centres that used HAART earliest to the three centres that used it latest showed a clear benefit to early HAART with a drop in hospitalization days by 41%, new AIDS cases by 41% and deaths by 69%. The proportion of patients with HAART rose to 27% and monthly health-care cost decreased by US$ 248 852 (i.e., by US$ 101 per patient per month). Late prescribing centres experienced a less marked effect with a drop in hospitalization days by 22%, new AIDS cases by 31%, and deaths by 32.5%. Proportion of patients with HAART rose to 12% and monthly health-care costs increased by US$ 113 578 (i.e., by US$ 38 per patient per month).This study supports the extensive use of HAART in HIV-infected patients.