A prospective, 96-week study of the impact of Trizivir super( registered ), Combivir super( registered )-nelfinavir, and lamivudine-stavudine-nelfinavir on lipids, metabolic parameters and efficacy in antiretroviral-naive patients: effect of sex and ethnicity

Objectives: To compare the lipid and metabolic effects, efficacy, and safety of twice-daily regimens of Trizivir super( registered ) (abacavir 300 mg-lamivudine 150 mg-zidovudine 300 mg triple nucleoside tablet; TZV), Combivir super( registered ) (lamivudine 150 mg-zidovudine 300 mg combination tablet; COM)+nelfinavir (NFV), and stavudine (d4 T)+lamivudine (3TC)+NFV. Study design: An international, phase 4, open-label, parallel-group, 34-centre study was conducted in 254 non-diabetic, antiretroviral-naive, HIV-infected out-patients with an HIV-1 RNA level of >1000 HIV-1 RNA copies-mL and less than or equal to 200 000 copies-mL and a CD4 cell count of >50 cells- mu L. Methods: Patients were randomized 1 : 1 : 1 to TZV twice daily (n=85), COM-NFV 1250 mg twice daily (n=88), or d4T 40 mg+3TC 150 mg+NFV 1250 mg twice daily (n=81) for 96 weeks. Treatments were compared using analysis of covariance (ANCOVA) with regard to changes from baseline in fasting lipids in the total population and in sex and ethnic subgroups. The proportions of patients achieving HIV-1 RNA