Comparison of metabolic abnormalities and clinical lipodystrophy 48 weeks after switching from HAART to Trizivir versus continued HAART: the Trizal study.
OBJECTIVE
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.


METHODS
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.


CONCLUSIONS
A switch from "standard" HAART to Trizivir was associated with an improvement in clinical LD and blood lipid abnormalities after 48 weeks.
Lafeuillade
Alain
A
Department of Infectious Diseases, Chalucet Hospital, Toulon, France. avps@club-internet.fr
Clumeck
Nathan
N
Mallolas
Josep
J
Jaeger
Hans
H
Livrozet
Jean-Michel
JM
Ferreira
Maria do Sameira
Mdo S
Johnson
Margaret
M
Cheret
Arnaud
A
Antoun
Zeina
Z
D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D001786:Blood Glucose / Q000187:drug effects; D015224:Dideoxynucleosides / Q000009:adverse effects* / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D039682:HIV-Associated Lipodystrophy Syndrome / Q000097:blood* / Q000139:chemically induced*; D006801:Humans; D019259:Lamivudine / Q000009:adverse effects* / Q000627:therapeutic use; D008055:Lipids / Q000097:blood; D008297:Male; D008659:Metabolic Diseases / Q000097:blood* / Q000139:chemically induced*; D013997:Time Factors; D015215:Zidovudine / Q000009:adverse effects* / Q000627:therapeutic use; D000099227:Abacavir
D019380:Anti-HIV Agents; D001786:Blood Glucose; D015224:Dideoxynucleosides; D004338:Drug Combinations; D019259:Lamivudine; D008055:Lipids; D015215:Zidovudine; C418262:abacavir, lamivudine, and zidovudine drug combination; D000099227:Abacavir