F. Maggiolo et al., Once-a-day HAART for HIV infection, SEVENTH EUROPEAN CONFERENCE ON CLINICAL ASPECTS AND TREATMENT OF HIV-INFECTION, 1999, pp. 103-106
A prospective, uncontrolled, open-label, cohort pilot study was conducted t
o evaluate the efficacy and safety of a once-a-day treatment with didanosin
e plus lamivudine plus efavirenz. Seventy-three out-patients were enrolled,
21.9% of them received treatment through a directly observed therapeutic s
cheme (DOT). At baseline the median HIV-RNA value was 93,470 copies/ml and
the median CD4+ T-cell count was 275 cell/mu l. The median decrease of HIV-
RNA was > 3.28 log (P < 0.05) and the median increase CD4+ T-cells was 132
cells/mu l (P = 0.003). Clinical signs of withdrawal syndrome were observed
among several patients chronically assuming methadone, whose mean dose was
raised from 41.4 to 64.5 mg/day (P = 0.003). Therapy was generally well ac
cepted and tolerated. Eight patients interrupted therapy because of side ef
fects. These preliminary data demonstrate the feasibility of a once-a-day t
herapy of HIV infection.