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 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.

• Authors: Alain Lafeuillade, Nathan Clumeck, Josep Mallolas, Hans Jaeger, Jean-Michel Livrozet, Maria do Sameira Ferreira, Margaret Johnson, Arnaud Cheret, Zeina Antoun, European Trizal team
• Journal: HIV clinical trials (HIV Clin Trials) 2003 Jan-Feb Vol. 4 Issue 1 Pg. 37-43 ISSN: 1528-4336 [Print] England
• PMID: 12577195 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-HIV Agents
• Blood Glucose
• Dideoxynucleosides
• Drug Combinations
• Lipids
• abacavir, lamivudine, and zidovudine drug combination
• Lamivudine
• Zidovudine

Topics

• Adult
• Anti-HIV Agents (adverse effects, therapeutic use)
• Antiretroviral Therapy, Highly Active (adverse effects)
• Blood Glucose (drug effects)
• Dideoxynucleosides (adverse effects, therapeutic use)
• Drug Combinations
• Female
• HIV Infections (drug therapy)
• HIV-1 (genetics, isolation & purification)
• HIV-Associated Lipodystrophy Syndrome (blood, chemically induced)
• Humans
• Lamivudine (adverse effects, therapeutic use)
• Lipids (blood)
• Male
• Metabolic Diseases (blood, chemically induced)
• Time Factors
• Zidovudine (adverse effects, therapeutic use)