The Effects of Thiazolidinediones on Metabolic Complications and Lipodystrophy in HIV-Infected Patients

Table 1

The basic characteristics of the studies with thiazolidinediones in HIV-infected, HAART-treated patients. HAART = highly active antiretroviral therapy, IR = insulin resistance, LA = lipoatrophy, OGTT = oral glucose tolerance test, LD = lipodystrophy.

Number of subjects	Study design	Study groups	Duration	Inclusion criteria	Reference
Rosiglitazone studies
8	Open label, uncontrolled	Rosiglitazone 8 mg/d	6–12 weeks	IR (defined by clamp)	Gelato et al. [54]
30	Randomized, double blind	Rosiglitazone 8 mg/d, or placebo	24 weeks	LA (clinical definition)	Sutinen et al. [55]
108	Randomized, double blind	Rosiglitazone 8 mg/d, or placebo	48 weeks	LA (limb fat% <20%, or limb fat% at least 10% less than truncal fat%)	Carr et al. [56]
28	Randomized, double blind	Rosiglitazone 4 mg/d, or placebo	3 months	LA (clinical definition) and IR (fasting insulin >15 𝜇IU/ml, or 2 h insulin [OGTT] >75 𝜇IU/ml)	Hadigan et al. [57]
39	Randomized, open label	Rosiglitazone 8 mg/d, or metformin 2 g/d	26 weeks	LA (clinical definition)	van Wijk et al. [58]
20	Open label, uncontrolled	Rosiglitazone 4 mg/d	24 weeks	No LD or IR requirements	Feldt et al. [59]
105	Randomized, double blind	Rosiglitazone 4 mg/d, or metformin 2 g/d, or rosiglitazone + metformin, or placebo	16 weeks	IR (fasting insulin >15 𝜇IU/ml, or 2 h insulin [OGTT] >75 𝜇IU/ml, or 2 h glucose [OGTT] >7.7 mmol/L and fasting insulin >10 𝜇IU/ml) and self-reported changes in body fat (including increased waist-to-hip ratio or waist circumference)	Mulligan et al. [60]
37	Randomized, double blind	Rosiglitazone 8 mg/d, or placebo	6 months	Body mass index 19–24 kg/m^2, no requirements on LD or IR	Haider et al. [61]
96	Randomized, double blind	Rosiglitazone 4 mg/d, or placebo	24 weeks	LD (clinical definition)	Cavalcanti et al. [62]
90	Randomized, open label	Rosiglitazone 4 mg/d, or metformin 1 g/d, or no treatment	48 weeks	IR (impaired fasting glucose or impaired glucose tolerance [OGTT], with fasting insulin >20 𝜇IU/ml)	Silič et al. [63]
Pioglitazone studies
11	Open label, uncontrolled	Pioglitazone 45 mg/d	6 months	LA (clinical definition)	Calmy et al. [64]
14	Randomized, double blind (2×2 factorial)	Pioglitazone 30–45 mg/d, or fenofibrate 200 mg/d, or pioglitazone + fenofibrate, or placebo	12 months	IR (impaired glucose tolerance [OGTT], or diabetes, or fasting insulin >20 𝜇IU/ml) and dyslipidemia	Gavrila et al. [65]
130	Randomized, double blind	Pioglitazone 30 mg/d, or placebo	48 weeks	LA (clinical definition)	Slama et al. [66]
Troglitazone study
6	Open label, uncontrolled	Troglitazone 400 mg/d	3 months	LD and newly diagnosed diabetes	Walli et al. [67]