Table 1. Baseline Characteristics of each Study and the Pooled Analysis Population.
| Study 1 (N = 410) | Study 2 (N = 396) | Pooled Analysis Population (N = 806) | |
|---|---|---|---|
| Demographics | |||
| Age, years, mean (SD) | 47.6 (7.4) | 47.6 (7.6) | 47.6 (7.5) |
| Males, N (%) | 352 (85.9) | 333 (84.1) | 685 (85.0) |
| Race, N (%) | |||
| Caucasian | 308 (75.1) | 305 (77.0) | 613 (76.0) |
| Asian | 2 (0.5) | 3 (0.8) | 5 (0.6) |
| African American | 59 (14.4) | 46 (11.6) | 105 (13.0) |
| Hispanic | 34 (8.3) | 35 (8.8) | 69 (8.6) |
| Other | 7 (1.7) | 7 (1.8) | 14 (1.7) |
| Disease and treatment history | |||
| Duration of HIV, years, mean (SD) a | 13.3 (5.3) | 14.0 (5.6) | 13.6 (5.4) |
| Duration of ART, months, mean (SD) | 53.7 (35.5) | 52.8 (36.4) | 53.3 (35.9) |
| PI-HAART, N (%) | 229 (55.9) | 216 (54.6) | 445 (55.2) |
| Body metrics | |||
| Weight, kg, mean (SD) | 89.8 (13.9) | 88.4 (14.3) | 89.1 (14.1) |
| BMI, kg/m2, mean (SD) | 29.2 (4.2) | 28.8 (4.2) | 29.0 (4.2) |
| BMI categories, kg/m2, N (%) | |||
| Normal (18.5 to <25) | 53 (12.9) | 70 (17.7) | 123 (15.3) |
| Overweight (25 to <30) | 214 (52.2) | 189 (47.7) | 403 (50.0) |
| Obese (≥30) | 143 (34.9) | 137 (34.6) | 280 (34.7) |
| WC, cm, mean (SD) | 104.4 (9.5) | 104.8 (9.0) | 104.6 (9.3) |
| WC categories, N (%) | |||
| High (>102 cm men, >88 cm women) | 217 (52.9) | 231 (58.3) | 448 (55.6) |
| Low/moderate (≤102 cm men, ≤88 cm women) | 193 (47.1) | 165 (41.7) | 358 (44.4) |
| Waist-to-hip ratio, mean (SD) | 1.05 (0.06) | 1.05 (0.07) | 1.05 (0.07) |
| VAT, cm2, mean (SD) a | 175.9 (76.9) | 189.2 (89.5) | 182.4 (83.5) |
| Disease risk scores | |||
| FRS, mean (SD) a | 6.1% (4.1%) | 6.9% (4.4%) | 6.5% (4.3%) |
| FRS categories, N (%) a | |||
| FRS <10% | 307 (74.9) | 310 (78.3) | 617 (76.6) |
| FRS ≥10% | 43 (10.5) | 78 (19.7) | 121 (15.0) |
| Missing a | 60 (14.6) | 8 (2.0) | 68 (8.4) |
| MetS-NCEP, N (%) | 176 (42.9) | 170 (42.9) | 346 (42.9) |
| MetS-IDF, N (%) | 296 (72.2) | 296 (74.8) | 592 (73.4) |
| Laboratory assessments | |||
| Triglycerides, mg/dL, mean (SD) | 236.5 (153.9) | 233.4 (230.5) | 234.9 (195.5) |
| Triglycerides >1.7 mmol/L, N (%) | 265 (64.6) | 241 (60.9) | 506 (62.8) |
| Vital signs | |||
| Systolic BP, mmHg, mean (SD) a | 124.6 (14.3) | 122.2 (12.1) | 123.4 (13.3) |
| Diastolic BP, mmHg, mean (SD) | 79.0 (8.9) | 78.3 (7.8) | 78.7 (8.4) |
Abbreviations: ART, antiretroviral therapy; BMI, body mass index; BP, blood pressure; FRS, Framingham Risk Score; HIV, human immunodeficiency virus; MetS-IDF, International Diabetes Foundation definition of metabolic syndrome; MetS-NCEP, National Cholesterol Education Program defined metabolic syndrome; PI–HAART, protease inhibitor-based highly active antiretroviral therapy; SD, standard deviation; VAT; visceral adipose tissue; WC, waist circumference.
a Statistically significant difference between Study 1 and Study 2 (p<0.05 from Student’s t-test for continuous or Fisher’s exact test for categorical data). No differences between the treatment and placebo groups were seen within the pooled analysis population after combining the studies.