Table 1.
Baseline Characteristics of Study Participants Stratified by Study Arma
| Overall | cART | Monotherapy | Switchers | |
|---|---|---|---|---|
| n | 101 | 33 | 68 | 18 |
| Age (median [IQR]) | 42.00 [33.00–47.00] | 43.00 [35.00–46.00] | 42.00 [32.75–47.00] | 42.50 [35.25–46.00] |
| Gender male, n (%) | 97 (96.0) | 32 (97.0) | 65 (95.6) | 18 (100.0) |
| Ethnicity, n (%) | … | |||
| White | 93 (92.1) | 31 (93.9) | 62 (91.2) | 18 (100.0) |
| Black | 5 (5.0) | 1 (3.0) | 4 (5.9) | 0 (0.0) |
| Asian | 2 (2.0) | 0 (0.0) | 2 (2.9) | 0 (0.0) |
| Hispanic | 1 (1.0) | 1 (3.0) | 0 (0.0) | 0 (0.0) |
| HIV-1 transmission risk, n (%) | … | … | … | … |
| MSM | 84 (83.2) | 28 (84.8) | 56 (82.4) | 17 (94.4) |
| HET | 15 (14.9) | 5 (15.2) | 10 (14.7) | 1 (5.6) |
| Other | 2 (2.0) | 0 (0.0) | 2 (2.9) | 0 (0.0) |
| HIV-1 subtype Bb, n (%) | 63 (67.7) | 19 (59.4) | 44 (72.1) | 10 (58.8) |
| BMI (kg/m2) (median [IQR]) | 23.81 [22.39–26.56] | 24.16 [22.50–27.36] | 23.74 [22.10–26.23] | 23.68 [22.50–27.09] |
| Fiebig stage, n (%) | ||||
| I–II | 23 (22.8) | 6 (18.2) | 17 (25.0) | 3 (16.7) |
| III–IV | 11 (10.9) | 5 (15.2) | 6 (8.8) | 3 (16.7) |
| V–VI | 47 (46.5) | 17 (51.5) | 30 (44.1) | 10 (55.6) |
| Not determined | 20 (19.8) | 5 (15.2) | 15 (22.1) | 2 (11.1) |
| D from infection until ART start (median [IQR]) | 38.00 [28.00–77.50] | 36.00 [29.00–113.00] | 38.00 [27.50–73.00] | 35.50 [25.25–76.50] |
| Y on ART before study entry (median [IQR]) | 3.60 [1.96–5.98] | 3.27 [2.02–5.49 | 3.81 [1.93–6.08] | 3.56 [2.27–5.48] |
| CD4 cell count baseline (cells/µL) (median [IQR]) | 716 [584–918] | 669 [545–881] | 730 [610–920] | 722 [611–853] |
| CD4 cell count nadir (cells/µL) (median [IQR]) | 358 [265–486] | 329 [269–442] | 377 [263–496] | 302 [255–419] |
| DTG-based regimen at baseline, n (%) | 46 (45.5) | 13 (39.4) | 33 (48.5) | 7 (38.9) |
Data are median (interquartile range [IQR]) or n (%) and assessed at baseline (day of randomization).
Abbreviations: ART, antiretroviral therapy; BMI, body mass index; cART, combination antiretroviral therapy; HET, heterosexual; HIV-1, human immunodeficiency virus type 1; MSM, men who have sex with men.
Data for cART and monotherapy groups previously reported as part of the EARLY-SIMPLFIED interim analysis [12].
Non-B subtypes: CRF01_AE, CRF02_AG, C, A, F, CRF12_BF, CRF20_BG-Recombinant.