Table 1.
Characteristics of Substudy Participants by Randomization Arm
| PI-mono (N = 75) | OT (N = 71) | P Value | Overall (N = 146) | |
|---|---|---|---|---|
| Age, Mean (SD) | 49 (9) | 46 (8) | .02 | 48 (9) |
| Sex, N (%) | ||||
| Male | 63 (84.0) | 63 (88.7) | .41 | 126 (86.3) |
| Ethnicity, N (%) | .41 | |||
| White | 58 (77.3) | 61 (85.9) | 119 (81.5) | |
| Black | 14 (18.7) | 8 (11.3) | 22 (15.1) | |
| Other | 3 (4.0) | 2 (2.8) | 5 (3.4) | |
| Years of formal education, Medi (IQR) | 15 (12–18) | 15 (13–18) | .53 | 15 (12–18) |
| CD4 cell count nadir, Median (IQR) | 170 (90–250) | 191 (100–269) | .41 | 180 (90–260) |
| CD4 cell count at entry, Median (IQR) | 621 (467–760) | 650 (540–830) | .27 | 640 (483–785) |
| HIV-RNA <50 copies/mL, N (%) | 72 (96.0) | 67 (95.7) | 1.00 | 139 (95.9) |
| Risky alcohol consumption, N (%)a | 22 (29.3) | 30 (42.9) | .09 | 52 (35.9) |
| Recreational drugs use, N (%) | .54 | |||
| In the past | 26 (35.1) | 30 (44.1) | 56 (39.4) | |
| Currently | 25 (33.8) | 19 (27.9) | 44 (31.0) | |
| Smokers at substudy visit, N (%) | 11 (14.7) | 24 (33.8) | .01 | 35 (24.0) |
| Depression/anxietyb | .63 | |||
| Moderate | 24 (34.8) | 20 (29.4) | 44 (32.1) | |
| Severe | 2 (2.9) | 4 (5.9) | 6 (4.4) | |
| Neurocognitive symptoms c | 17 (23.0) | 16 (22.5) | .95 | 17 (23.0) |
| ART exposure at substudy visit | <.001 | |||
| 2NRTI + 1NNRTI | 9 (12.0) | 22 (31.0) | 31 (21.2) | |
| 2NRTI + 1PI | 15 (20.0) | 40 (56.3) | 55 (37.7) | |
| PI monotherapy | 49 (65.3) | 5 (7.0) | 54 (37.0) | |
| Other ART combination | 2 (2.7) | 3 (4.2) | 5 (3.4) | |
| Off ART | 0 (0.0) | 1 (1.4) | 1 (0.7) |
Abbreviations: ART, antiretroviral therapy; HIV, human immunodeficiency virus; IQR, interquartile range; NNRTI, non-nucleoside reverse transcriptase inhibitors; NRTI, nucleoside reverse transcriptase inhibitors; OT, ongoing triple therapy; PI, protease inhibitor; SD, standard deviation.
a Based on AUDIT questionnaire score.
b Based on EQ-5D Health Status questionnaire.
c Based on MOS-HIV QoL questionnaire.