Author(s):
Lafeuillade, A ; Clumeck, N ; Mallolas, J ; Jaeger, H ; Livrozet, JM ; Ferreira, MS ; Jonhson, S ; Cheret, A ; Antoun, Z ; European Trizal team.
Date: 2003
Persistent ID: http://hdl.handle.net/10400.23/560
Origin: Repositório Científico do Hospital de Braga
Subject(s): Terapêutica Anti-Retrovírica; Terapêutica Anti-Retrovírica de Elevada Potência; Síndrome de Lipodistrofia Associada ao HIV; Infecções por HIV; Lamivudina; Zidovudina; Doenças Metabólicas
Description
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 Trizivir (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 >or=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 lt.001). Median triglyceride levels decreased in the Trizivir arm but increased in the continued HAART arm (-0.17 and +0.01 mmol/L; p =.006). Suppression of VL was maintained in most patients with no differences between the two arms. CONCLUSION: A switch from "standard" HAART to Trizivir was associated with an improvement in clinical LD and blood lipid abnormalities after 48 weeks.