TABLE 1.
Baseline characteristics of START Pulmonary Substudy participants by region
| Total | Africa | Asia | Europe/Israel/Australia | Mexico/South America | United States | |
|---|---|---|---|---|---|---|
| 1026 (100.0%) | 328 (32.0%) | 103 (10.0%) | 313 (30.5%) | 191 (18.6%) | 91 (8.9%) | |
| Demographics | ||||||
| Age (years) | 36 (30, 44) | 37 (32, 44) | 36 (30, 41) | 38 (31, 45) | 34 (29, 40) | 36 (29, 47) |
| Female | 299 (29.1%) | 211 (64.3%) | 27 (26.2%) | 26 (8.3%) | 26 (13.6%) | 9 (9.9%) |
| Race | ||||||
| Black | 387 (37.7%) | 321 (97.9%) | 0 (0.0%) | 22 (7.0%) | 0 (0.0%) | 44 (48.4%) |
| Latino/Hispanic | 179 (17.4%) | 0 (0.0%) | 0 (0.0%) | 14 (4.5%) | 153 (80.1%) | 12 (13.2%) |
| Asian | 105 (10.2%) | 0 (0.0%) | 101 (98.1%) | 1 (0.3%) | 0 (0.0%) | 3 (3.3%) |
| White | 344 (33.5%) | 6 (1.8%) | 1 (1.0%) | 268 (85.6%) | 38 (19.9%) | 31 (34.1%) |
| Other | 11 (1.1%) | 1 (0.3%) | 1 (1.0%) | 8 (2.6%) | 0 (0.0%) | 1 (1.1%) |
| HIV Factors | ||||||
| Likely mode of HIV infection | ||||||
| Injecting drug use | 14 (1.4%) | 0 (0.0%) | 1 (1.0%) | 5 (1.6%) | 2 (1.0%) | 6 (6.6%) |
| Male sexual contact with person of same sex | 505 (49.2%) | 5 (1.5%) | 59 (57.3%) | 238 (76.0%) | 138 (72.3%) | 65 (71.4%) |
| Sexual contact with person of opposite sex | 450 (43.9%) | 306 (93.3%) | 34 (33.0%) | 46 (14.7%) | 46 (24.1%) | 18 (19.8%) |
| Other/unknown | 57 (5.6%) | 17 (5.2%) | 9 (8.7%) | 24 (7.7%) | 5 (2.6%) | 2 (2.2%) |
| Time since first HIV diagnosis, years | 1.2 (0.4, 3.5) | 1.5 (0.5, 4.8) | 0.8 (0.2, 3.4) | 1.2 (0.5, 3.5) | 0.6 (0.3, 2.2) | 1.5 (0.4, 4.6) |
| CD4 cell count (cells/μL) | 648 (583, 767) | 695 (603, 814) | 618 (561, 728) | 634 (581, 738) | 632 (574, 718) | 674 (582, 773) |
| CD8 cell count (cells/μL) | 1019 (758, 1394) | 922 (692, 1275) | 1079 (805, 1452) | 1069 (800, 1547) | 1023 (770, 1383) | 959 (765, 1400) |
| CD4/CD8 ratio | 0.66 (0.48, 0.94) | 0.79 (0.56, 1.06) | 0.58 (0.44, 0.81) | 0.62 (0.44, 0.81) | 0.63 (0.45, 0.91) | 0.66 (0.51, 0.99) |
| Nadir CD4 (cells/μL) | 552 (486, 661) | 605 (519, 740) | 542 (477, 618) | 524 (452, 608) | 545 (492, 630) | 564 (479, 688) |
| Log10 HIV RNA (copies/mL) | 4.2 (3.5, 4.7) | 3.8 (3.0, 4.6) | 4.5 (3.9, 4.9) | 4.3 (3.8, 4.7) | 4.4 (3.9, 4.8) | 3.9 (3.3, 4.5) |
| HIV RNA ≤ 400 copies/mL | 97 (9.5%) | 62 (19.0%) | 6 (5.9%) | 9 (2.9%) | 9 (4.7%) | 11 (12.1%) |
| Medical History | ||||||
| Body mass index, kg/m2 | 24.8 (22.2, 28.4) | 25.7 (22.2, 31.8) | 22.8 (20.7, 25.7) | 23.8 (22.2, 26.6) | 25.5 (23.2, 28.2) | 26.5 (23.1, 30.7) |
| Prior cardiovascular disease | 7 (0.7%) | 0 (0.0%) | 1 (1.0%) | 3 (1.0%) | 1 (0.5%) | 2 (2.2%) |
| Hypertension | 192 (18.7%) | 65 (19.8%) | 9 (8.7%) | 73 (23.3%) | 17 (8.9%) | 28 (30.8%) |
| Diabetes | 37 (3.6%) | 20 (6.1%) | 2 (1.9%) | 5 (1.6%) | 6 (3.1%) | 4 (4.4%) |
| Hepatitis B or C | 72 (7.1%) | 22 (6.7%) | 10 (9.7%) | 23 (7.5%) | 12 (6.3%) | 5 (5.6%) |
| Osteoporosis | 2 (0.2%) | 0 (0.0%) | 0 (0.0%) | 1 (0.3%) | 0 (0.0%) | 1 (1.1%) |
| Smoking status | ||||||
| Current smoker | 290 (28.3%) | 46 (14.0%) | 20 (19.4%) | 140 (44.7%) | 54 (28.3%) | 30 (33.0%) |
| Former smoker | 111 (10.8%) | 19 (5.8%) | 11 (10.7%) | 42 (13.4%) | 27 (14.1%) | 12 (13.2%) |
| Never smoker | 625 (60.9%) | 263 (80.2%) | 72 (69.9%) | 131 (41.9%) | 110 (57.6%) | 49 (53.8%) |
| Pack years smoking (current and former smokers only) | 6.0 (2.0, 15.0) | 2.5 (1.2, 5.0) | 4.3 (1.2, 9.5) | 10.0 (5.0, 20.0) | 4.3 (1.0, 10.5) | 4.6 (1.5, 12.0) |
Data shown as n(%) or median (interquartile range).
Prior cardiovascular disease = history of stroke, myocardial infarction, or coronary revascularisation.
Hypertension= use of blood pressure-lowering medications, systolic blood pressure ≥140 mmHg, or diastolic blood pressure ≥90 mmHg
Diabetes= prior diagnosis of diabetes, use of diabetes medication, or fasting baseline glucose ≥126 mg/dL.
Hepatitis B = positive Hepatitis B surface antigen test in the year prior to randomisation
Hepatitis C = positive Hepatitis C core antibody test any time prior to randomisation
Osteoporosis= prior diagnosis of osteoporosis or use of osteoporosis medication