Table 1.
Baseline characteristics for n=826 randomised participants
| Characteristic1 | Stage 1 (n=107) | Stage 2 (n=719) | Total | |||
|---|---|---|---|---|---|---|
| DRV/r + 2NRTI (n=52) | DRV/r + DTG (n=55) | DRV/r + 2NRTI (n=209) | DRV/r + DTG (n=216) | DTG + TDF/XTC (n=294) | (n=826) | |
|
Age at randomisation (years):
Mean (SD) Median [IQR} |
39.2 (9.6) 39.0 [33.5, 44.5] |
40.0 (10.6) 42.0 [32.0, 50.0] |
39.7 (9.6) 40.0 [34.0, 46.0] |
39.2 (9.6) 39.0 [33.0, 44.5] |
39.0 (9.6) 39.0 [32.0, 46.0] |
39.4 (10.0) 39.0 [33.0, 46.0] |
| <40 | 27 (51.9) | 25 (45.5) | 100 (47.9) | 120 (55.6) | 152 (51.7) | 422 (51.3) |
| 40–44 | 12 (23.1) | 8 (14.6) | 46 (22.0) | 35 (16.2) | 52 (17.7) | 153 (18.5) |
| 45–54 | 9 (17.3) | 20 (36.4) | 53 (25.4) | 50 (23.2) | 68 (23.1) | 200 (24.2) |
| 55+ | 4 (7.7) | 2 (3.6) | 10 (4.8) | 11 (5.1) | 22 (7.5) | 49 (5.9) |
| Weight (kg) | 61.3 (12.6) 58.7 [52.9, 66.0] |
61.5 (14.5) 60.4 [49.6, 67.5] |
66.8 (15.9) 64.2 [57.0, 74.0] |
63.6 (15.7) 61.4 [52.2, 71.5] |
65.6 (14.9) 64.0 [54.8, 74.0] |
64.8 (15.3) 62.7 [54.1, 72.8] |
|
BMI (kg/m2): Mean (SD) Median [IQR] |
23.1 (4.4) 22.5 [20.1, 24.7] |
22.8 (5.2) 21.6 [19.3, 25.1] |
24.7 (5.4) 23.6 [21.0, 27.4] |
23.8 (5.8) 22.5 [19.8, 26.7] |
24.5 (5.7) 23.5 [20.4, 27.1] |
24.2 (5.6) 23.0 [20.3, 26.8] |
| Underweight [BMI <18.5] | 6 (11.5) | 8 (14.6) | 12 (17.1) | 32 (14.8) | 26 (8.9) | 84 (10.2) |
| Normal [18.5 ≤ BMI <25] | 34 (65.4) | 33 (60.0) | 116 (55.5) | 111 (51.4) | 155 (52.7) | 449 (54.4) |
| Overweight [25≤ BMI <30] | 8 (15.4) | 11 (20.0) | 47 (22.5) | 44 (20.4) | 73(24.8) | 183(22.1) |
| Obese [BMI ≥30] | 4 (7.7) | 3 (5.5) | 34 (16.3) | 29 (13.4) | 40 (13.6) | 110 (13.3) |
| Sex | ||||||
| Female | 29 (55.8) | 26 (47.3) | 113 (54.1) | 122 (56.5) | 160 (54.4) | 450 (54.5) |
| Male | 23 (44.2) | 29 (52.7) | 96 (45.9) | 93 (43.5) | 134 (45.7) | 376 (45.5) |
| Ethnicity | ||||||
| White | 0 (0.0) | 0 (0.0) | 2 (1.0) | 4 (1.9) | 7 (2.4) | 13 (1.6) |
| Asian | 19 (36.5) | 19 (34.6) | 51 (24.4) | 51 (23.6) | 67 (22.8) | 207 (25.1) |
| Black | 32 (61.5) | 36 (65.5) | 145 (69.4) | 149 (69.0) | 208 (70.8) | 570 (69.0) |
| Hispanic/Latino | 0 (0.0) | 0 (0.0) | 11 (5.3) | 12 (5.6) | 11 (3.7) | 34 (4.1) |
| Other | 1 (1.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 2 (0.2) |
|
CD4 T-cell count (cell/µL)
Mean (SD) Median [IQR] |
252.1 (221.1) 186.0 [92.0, 344.5] |
212.9 (182.2) 166.0 [61.0, 298.0] |
247.5 (213.5) 194.5 [84.5, 354.5] |
249.1 (202.6) 213.0 [93.0, 350.0] |
266.1 (218.8) 221.5 [110.5, 375.1] |
252.5 (211.4) 206.0 [93.0, 354.2] |
| <50 | 9 (17.3) | 10 (18.2) | 33 (15.8) | 28 (13.0) | 34 (11.6) | 114 (13.8) |
| 50 – 199 | 19 (36.5) | 21 (38.2) | 70 (33.5) | 71 (32.9) | 98 (33.3) | 279 (33.8) |
| 200 – 349 | 11 (21.2) | 12 (21.8) | 50 (23.9) | 59 (27.3) | 76 (25.9) | 208 (25.2) |
| ≥350 | 13 (25.0) | 12 (21.8) | 51 (24.4) | 53 (24.5) | 80 (27.2) | 209 (25.3) |
| Unknown | 0 (0.0) | 0 (0.0) | 5 (2.4) | 5 (2.3) | 6 (2.0) | 16 (1.9) |
|
HIV-RNA (copies/mL): median
[IQR] |
17000.0 [2200.0, 49561.0] |
21500.0 [5209.0, 87744.0] |
14195.0 [3109.0, 70923.0] |
13162.0 [3600.0, 72660.5] |
16000.0 [4100.0, 57891.0] |
15400.0 [3600.0, 65986.0] |
| Log10(HIV-RNA): Median [IQR] | 4.2 [3.3, 4.7] | 4.3 [3.7, 4.9] | 4.2 [3.5, 4.9] | 4.1 [3.6, 4.9] | 4.2 [3.6, 4.8] | 4.2[3.6, 4.8] |
|
HIV-RNA (copies/mL)
<200 |
2 (3.9) | 1 (1.8) | 4 (1.9) | 3 (1.4) | 5 (1.7) | 15 (1.8) |
| 200 – 499 | 2 (3.9) | 3 (5.5) | 8 (3.8) | 4 (1.9) | (3.1) | 26 (3.2) |
| 500 – 49,000 | 35 (67.3) | 30 (54.6) | 135 (64.6) | 143 (66.2) | 199 (67.7) | 542(65.6) |
| 50, 000 – 100, 000 | 6 (11.5) | 8 (14.6) | 24 (11.5) | 23 (10.7) | 32 (10.9) | 93 (11.3) |
| >100, 000 | 7 (13.5) | 13 (23.6) | 38 (18.2) | 43 (19.9) | 48 (16.3) | 149 (18.0) |
| Unknown | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 1 (0.1) |
| Mode of HIV transmission | ||||||
| Homosexual contact | 4 (7.7) | 9 (16.4) | 31 (14.8) | 21 (9.7) | 27 (9.2) | 92 (11.2) |
| Heterosexual contact | 40 (76.9) | 42 (76.4) | 156 (74.6) | 179 (82.9) | 239 (81.3) | 656 (79.4) |
| Injecting drug use | 1 (1.9) | 0 (0.0) | 1 (0.5) | 0 (0.0) | 2 (0.7) | 4 (0.5) |
| Blood transfusion | 0 (0.0) | 0 (0.0) | 3 (1.4) | 3 (1.4) | 2 (0.7) | 8 (1.0) |
| Other | 7 (13.5) | 4 (7.3) | 18 (8.6) | 13 (6.0) | 24 (8.2) | 66 (8.0) |
| Absolute neutrophil count (cells/µL) | 2.4 (1.0) 2.1 [1.7, 3.0] |
2.4 (1.4) 2.0 [1.2, 3.1] |
2.4 (1.2) 2.2 [1.6, 3.0] |
2.4 (1.9) 2.1 [1.5, 2.8] |
2.3 (1.2) 2.0 [1.5, 3.0] |
2.4 (1.4) 2.1 [1.5, 2.9] |
| Haemoglobin (g/dL) |
12.9 (1.9) 13.0 [11.9, 14.2] |
12.8 (1.7) 12.9 [11.9, 14.1] |
12.7 (2.0) 12.8 [11.4, 14.2] |
12.3 (2.1) 12.4 [11.0, 13.9] |
12.6 (2.0) 12.7 [11.3, 13.9] |
12.6 (2.0) 12.7 [11.3, 14.0] |
| Platelet count (cells/µl) |
245.3 (87.3) 236.0 [193.0, 288.5] |
248.3 (79.3) 237.0 [203.0, 300.0] |
241.2 (79.8) 235.0 [194.0, 238.0] |
253.2 (113.0) 240.0 [198.0, 294.0] |
247.6 (80.2) 238.5 [193,0, 293.5] |
247.5 (90.1) 237.0 [196.0, 290.0] |
| Serum ALT (U/L) | 32.3 (46.0) 24.0 [16.0, 32.0] |
31.5 (18.7) 26.0 [18.0, 36.0] |
28.6 (22.6) 23.0 [16.1, 33.0] |
28.3 (17.4) 23.8 [17.0, 34.5] |
28.5 (17.2) 25.0 [17.0, 36.0] |
28.9 (21.7) 24.0 [17.0, 34.0] |
| eGFR (mL/min/1.73m2) | 117.9 (23.5) 119.7 [104.7, 132.0] |
118.1 (24.4) 118.2 [104.1, 130.4] |
121.7 (21.2) 121.4 [107.9, 136.6] |
121.4 (23.5) 123.2 [110.7, 136.9] |
122.8 (21.5) 123.6 [109.4, 136.8] |
121.5 (22.3) 122.3 [108.5, 136.4] |
|
Duration ART: years mean (SD) median [IQR] |
5.1 (3.1) 5.1 [2.9, 7.5] |
6.1 (4.1) 5.8 [2.7, 8.0] |
5.5 (3.8) 4.7 [2.5, 7.9] |
5.4 (4.4) 4.4 [1.8, 8.2] |
6.1 (4.4) 5.4 [2.3, 8.9] |
5.7 (4.2) 5.0 [2.2, 8.3] |
1
.All categorical characteristics are presented with n (%) of total, all clinical continuous characteristics are presented with mean (SD) and median [IQR]. SD=standard deviation, IQR = interquartile range.