A randomized, comparative study of lamivudine plus stavudine, with indinavir or nelfinavir, in treatment-experienced HIV-infected patients

Objective: To compare adherence and clinical outcome with two modalities of highly active antiretroviral therapy (HAART), in HIV-infected patients. Design: Randomized, open-label, prospective study. Setting: Tertiary care centre in Spain. Patients: A total of 112 non-naive HIV-infected patients, recruited from Ma rch 1998 through August 1998, were studied. Interventions: Triple drug therapy with stavudine and lamivudine, plus indi navir or nelfinavir. Main outcome measures: Adherence, side-effects, and immunological, virologi cal, and clinical efficacy of treatment were assessed at 3-month intervals. Results: After a median follow-up of 9 months, 32% of patients in the indin avir group versus 50% of those in the nelfinavir group showed adequate adhe rence in all clinical appointments (P = 0.0559). Adherence was superior in the nelfinavir group in every visit. After 6 months of treatment 48% of sub jects in the indinavir group and 70% of those in the nelfinavir group exhib ited adequate adherence (P = 0.0311). After 9 months 35% of patients in the indinavir group and 59% of those in the nelfinavir group showed adequate a dherence (P = 0.0291). Side-effects provoked discontinuation of treatment i n 34% of patients in the indinavir group and 12% of patients in the nelfina vir group (P = 0.0073). Immunological and virological efficacy were similar in both groups. Conclusions: Adherence to a HAART regimen with stavudine plus lamivudine pl us nelfinavir was superior to a regimen with stavudine plus lamivudine plus indinavir. Side-effects provoked more discontinuation of treatment in the indinavir group than in the nelfinavir group. (C) 2000 Lippincott Williams & Wilkins.