Table 1.
Baseline Characteristics
| Characteristic | Body Composition Substudy | SMART Study | ||
|---|---|---|---|---|
| Overall (n=275) | Drug Conservation Group (n=142) | Viral Suppression Group (n=133) | Overall (n=5472) | |
| Demographics | ||||
| Age (years) (median. IQR) | 44.0 (39.0, 50.0) | 45.0 | 43.0 | 43 |
| Female (%) | 18.5 | 14.1 | 23.3 | 27.2 |
| Race/ethnicity | ||||
| Black or African American (%) | 25.8 | 23.9 | 27.8 | 29.1 |
| Latino or Hispanic (non-black) (%) | 17.1 | 18.3 | 15.8 | 21.1 |
| White (%) | 55.3 | 56.3 | 54.1 | 43.6 |
| Other or Unknown (%) | 1.8 | 1.4 | 2.3 | 6.2 |
| Probable HIV Transmission Modes | ||||
| Male-Male Sexual Contact (%) | 62.9 | 68.3 | 57.1 | 49.9 |
| Heterosexual Contact (%) | 33.1 | 31.0 | 35.3 | 45.0 |
| IV Drug Use (%) | 13.8 | 14.1 | 13.5 | 9.7 |
| Other (%) | 6.9 | 4.9 | 9.0 | 8.1 |
| Years Since Known HIV-infected [median (IQR)] | 8.5 (5.0, 13.6) | 8.7 | 7.9 | |
| Clinical Characteristics | ||||
| Prior AIDS Diagnosis (%) | 22.2 | 24.6 | 19.5 | 23.9 |
| Hepatitis B (%) | 3.7 | 2.9 | 4.6 | 2.3 |
| Hepatitis C (%) | 16.1 | 16.4 | 15.8 | 14.8 |
| Current Smoker (%) | 45.8 | 41.5 | 50.4 | 40.5 |
| On Lipid-lowering Drugs (%) | 22.2 | 22.5 | 21.8 | |
| CD4+ (cells/mm3) [median (IQR)] | 554 (437, 783) | 590 | 525 | 597 |
| Nadir CD4+ (cells/mm3) [median (IQR)] | 260 (150, 377) | 256 | 270 | 250 |
| HIV RNA ≤ 400 copies/mL (%) | 57.5 | 64.8 | 49.6 | 71.7 |
| ART History | ||||
| ART Naïve (%) | 7.6 | 5.6 | 9.8 | 4.6 |
| On ART at baseline (%) | 74.2 | 79.6 | 68.4 | 83.9 |
| On PI (%) | 35.6 | 38.7 | 32.3 | 45.2 |
| On NNRTI (%) | 36.7 | 40.1 | 33.1 | 49.0 |
| On Thymidine NRTI (%) | 52.0 | 56.3 | 47.4 | 58.7 |
| Years Since Start of ART [median (IQR)] | 6.0 (3.4, 8.1) | 5.9 | 6.2 | 6.0 |
| Years on a PI [median (IQR)] | 2.5 (0.0, 4.5) | 2.5 | 1.5 | 2.5 |
| Abnormal Body Fat | ||||
| Peripheral LipoatrophyA (%) | 19.3 | 20.4 | 18.0 | - |
| Abnormal Fat AccumulationA (%) | 20.7 | 22.5 | 18.8 | - |
| LipodystrophyA,B (%) | 8.4 | 8.5 | 8.3 | - |
| Body Composition | ||||
| Body mass index (kg/m2) [median (IQR)] | 25.6 (23.3, 28.8) | 25.7 | 25.6 | 25.9 |
| Limb fat (kg) [median (IQR)] | 6.6 (4.0, 9.4) | 6.5 | 6.7 | - |
| Limb fat (% of limb mass) [median (IQR)] | 19.5 (13.9, 27.3) | 19.6 | 19.4 | - |
| Lean body mass (kg) [median (IQR)] | 57.8 (49.0, 63.5) | 57.8 | 58.2 | - |
| Total body fat (kg) [median (IQR)] | 18.0 (12.9, 24.8) | 18.4 | 17.5 | - |
| VAT (cm2) [median (IQR)] | 117 (69, 181) | 119 | 117 | - |
| SAT (cm2) [median (IQR)] | 143 (88, 207) | 139 | 146 | - |
| Satisfaction with Body Image (0–100)C (%) | 70 (50, 80) | 70 | 70 | 75 |
| Metabolic Values (≥ 8 hours fasting)D | ||||
| Total cholesterol (mg/dL) [median (IQR)] | 183 (159, 217) | 193 | 181 | 191 |
| LDL cholesterol (mg/dL) [median (IQR)] | 109 (84, 133) | 112 | 107 | 112 |
| HDL cholesterol (mg/dL) [median (IQR)] | 39 (31, 47) | 39 | 38 | 41 |
| Total:HDL cholesterol ratio [median (IQR)] | 4.7 (3.7, 6.0) | 4.8 | 4.6 | 4.6 |
| Triglycerides (mg/dL) [median (IQR)] | 167 (114, 260) | 185 | 156 | 163 |
| Lactate (mmol/L) [median (IQR)] | 1.4 (1.1, 1.7) | 1.3 | 1.4 | - |
| C-Peptide (ng/mL) [median (IQR)] | 2.8 (1.9, 3.7) | 2.8 | 2.8 | - |
| Insulin (μU/mL) [median (IQR)] | 11 (7, 18) | 11 | 12 | - |
| Glucose (mg/dL) [median (IQR)] | 93 (86, 101) | 94 | 92 | - |
| Hemoglobin A1C (% of total hemoglobin) [median (IQR)] | 5.1 (4.8, 5.5) | 5.0 | 5.2 | - |
| HOMAE [median (IQR)] | 2.6 (1.7, 4.5) | 2.5 | 2.6 | - |
Most baseline characteristics remained stable with respect to date of enrolment, including demographics, body fat and metabolic parameters, and the proportion of participants using ART at baseline. The proportion with prior AIDS decreased from 26% among those enrolled in the first two years of the study (n=172) to 17% among those enrolled later (n=103). Similarly, the proportion of participants who used PIs and thymidine NRTIs at baseline decreased from 38% to 32% and from 56% to 44%, respectively.
Physician-assessed, moderate or severe
Participants with both peripheral lipoatropy and abnormal fat accumulation.
Patient self-report using a visual analogue scale from 0–100, with 0 being the worst and 100 the best.
The fasting requirement applied only to the Body Composition substudy, not the parent SMART study.
HOMA = (fasting plasma glucose [mmol/l]) * (serum insulin [μU/l])/22.5
Abbreviations: CT, computed tomography; HOMA, Homeostasis Model Assessment of Insulin Resistance; PI, protease inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; SAT, subcutaneous adipose tissue; VAT, visceral adipose tissue.