A randomized, placebo-controlled trial of rosiglitazone for HIV-related lipoatrophy.

BACKGROUND: Thiazolidinediones such as rosiglitazone may have benefit in ameliorating human immunodeficiency virus (HIV) lipoatrophy.

METHODS: HIV-positive patients receiving stable, protease inhibitor-containing highly active antiretroviral therapy with HIV lipodystrophy were prospectively randomized to rosiglitazone (4 mg/day) or placebo. The primary end point was the 24-week percentage change in arm fat by dual-energy x-ray absorptiometry (DEXA). Clinical and anthropometric evaluations, fasting lipid parameters, oral glucose tolerance testing, CD36 expression, quality of life measures, and DEXA scanning were performed at baseline and week 24.

RESULTS: Seventy-eight of the 96 enrolled patients were evaluated. Median age was 46.8 years, 97.4% were male, and 54% were treated with thymidine analogues. Median baseline limb fat was 3.76 and 2.99 kg in the rosiglitazone and control groups, respectively. Median changes in arm, leg, trunk, and total body fat at 24 weeks were not significantly different between groups (7.1% vs. 5.0% [P=.94]; 0.1% vs. -2.4% [P=.90]; 1.2% vs. -1.4% [P=.81]; and 1.7% vs. 0.4% [P=.76]). There were no significant changes in secondary end points. There was no correlation between changes in body fat or treatment-arm and CD36 expression.

CONCLUSIONS: This randomized, placebo-controlled trial did not show benefit of 4 mg/day of rosiglitazone on lipoatrophy or metabolic parameters in patients with HIV lipodystrophy.