Comparison of metabolic abnormalities and clinical lipodystrophy 48 weeks after switching from HAART to Trizivir™ versus continued HAART: The trizal study

Abstract

Purpose: To analyze the evolution of clinical lipodystrophy (LD) and metabolic abnormalities in patients continuing to receive HAART versus patients switched to Trizivir™ (zidovudine, lamivudine, abacavir) after 48 weeks. Method: Patients treated with HAART >6 months with plasma HIV-1 RNA viral load (VL) <400 copies/mL and <50 copies/mL at screening were randomly assigned to continue HAART (103 patients) or to receive TrizivirZ™ (106 patients). Clinical LD was evaluated using a standardized patient questionnaire only at baseline, weeks 4 and 8, and then every 8 weeks until Week 48. Laboratory evaluation was performed every 4 weeks. Results: The proportion of patients exhibiting ≥1 LD symptom at baseline was 40% in the Trizivir™ arm and 50% in HAART arm (difference not significant). After 48 weeks, the prevalence was 28% and 42% respectively (p = .03), and the median number of LD symptoms per patient was 2 in the Trizivir™ arm and 4 in the continued HAART arm (p = .016). Median decreases in cholesterol levels over the 48-week study period were greater in the Trizivir™ arm than in the continued HAART arm (-0.80 vs. -0.44 mmol/L; p