Table 1:
Baseline characteristics of the study population by Cohort
| A | B | C | D | Total | ||
|---|---|---|---|---|---|---|
| (n=287) | (n=154) | (n=70) | (n=34) | (n=545) | ||
| Age (years) | Median (IQR) | 40 (33, 46) | 42 (36, 48) | 42 (35, 46) | 42(38, 48) | 41 (35, 47) |
| Sex (n, %) | Female | 160 (56%) | 61 (40%) | 23 (33%) | 14(41%) | 258 (47%) |
| Male | 127 (44%) | 93 (60%) | 47 (67%) | 20 (59%) | 287 (53%) | |
| Ethnicity (n, %) | Hispanic or latino | 38 (13%) | 16 (10%) | 1 (1%) | 8 (24%) | 63 (12%) |
| Not hispanic or latino | 241 (84%) | 129 (84%) | 60 (86%) | 24 (71%) | 454 (83%) | |
| Unknown or not reported | 8 (3%) | 9 (6%) | 9 (13%) | 2 (6%) | 28 (5%) | |
| Region (n, %) | Africa | 148 (52%) | 85 (55%) | 32 (46%) | 18 (53%) | 283 (52%) |
| Asia | 62 (22%) | 41 (27%) | 35 (50%) | 8 (24%) | 146 (27%) | |
| South America | 43 (15%) | 19 (12%) | 1 (1%) | 8 (24%) | 71 (13%) | |
| Caribbean | 34 (12%) | 9 (6%) | 2 (3%) | 0 (0%) | 45 (8%) | |
| CD4 cell count (cells/mm3) | Median (IQR) | 171 (72, 288) | 191 (68, 315) | 161 (71, 289) | 189 (62, 361) | 175 (71, 308) |
| n (%) < 50 cells/mm3 | 50 (17%) | 29 (19%) | 9 (13%) | 7 (21%) | 95 (17%) | |
| HIV-1 RNA (log10 copies/mL) | Median (IQR) | 4.3 (3.3, 4.9) | 4.6 (3.7, 5.3) | 4.6 (3.7, 5.4) | 4.2 (3.7, 5.1) | 4.4 (3.5, 5.2) |
| n (%) ≥ 100,000 copies/mL | 68 (24%) | 60 (39%) | 27 (39%) | 12 (35%) | 167 (31%) | |
| HIV-1 subtype | C | 138 (48%) | 68 (44%) | 51 (73%) | 12 (35%) | 269 (49%) |
| B | 74 (26%) | 27 (18%) | 3 (4%) | 8 (24%) | 112 (21%) | |
| Al | 49 (17%) | 33 (21%) | 8 (11%) | 7 (21%) | 97 (18%) | |
| D | 12 (4%) | 18 (12%) | 3 (4%) | 2 (6%) | 35 (6%) | |
| CRF01_AE | 8 (3%) | 5 (3%) | 3 (4%) | 3 (9%) | 19 (3%) | |
| Other | 6 (2%) | 3 (2%) | 2 (3%) | 2 (6%) | 13 (2%) | |
| Hepatitis B surface antigen (n, %) | Positive | 14 (5%) | 8 (5%) | 3 (4%) | 4 (12%) | 29 (5%) |
| Body Mass Index (kg/m2) (n, %) | Underweight (< 18) | 51 (18%) | 20 (13%) | 13 (19%) | 6 (18%) | 90 (16%) |
| Normal (18 – <25) | 162 (57%) | 93 (60%) | 44 (63%) | 16 (47%) | 315 (58%) | |
| Overweight (25 – <30) | 47 (16%) | 29 (19%) | 8 (11%) | 9 (26%) | 93 (17%) | |
| Obese (30+) | 27 (9%) | 12 (8%) | 5 (7%) | 3 (9%) | 47 (9%) | |
| Years on antiretroviral therapy | Median (IQR) | 7.9 (5.5, 10.0) | 8.0 (6.0, 10.9) | 8.1 (6.2, 9.9) | 7.8 (5.6, 10.1) | 7.9 (5.9, 10.2) |
| Years from last NNRTI to entry | Median (IQR) | 3.2 (1.8, 5.0) | 3.5 (2.1, 6.1) | 3.0 (1.8, 4.3) | 3.8 (2.4, 4.7) | 3.3 (1.9, 5.0) |
| NRTI Exposure (n, %) | Tenofovir (TDF) | 232 (81%) | 132 (86%) | 66 (94%) | 28 (82%) | 458 (84%) |
| Zidovudine (ZDV) | 229 (80%) | 122 (79%) | 52 (74%) | 26 (76%) | 429 (79%) | |
| Lamivudine (3TC) | 287 (100%) | 153 (99%) | 70 (100%) | 34 (100%) | 544 (100%) | |
| Stavudine (D4T) | 152 (53%) | 93 (60%) | 48 (69%) | 17 (50%) | 310 (57%) | |
| TDF use in initial 1st line regimen | n (%) | 38 (13%) | 17 (11%) | 5 (7%) | 3 (9%) | 63 (12%) |
| TDF use during NNRTI use | n (%) | 81 (28%) | 45 (29%) | 19 (27%) | 7 (21%) | 152 (28%) |
| TDF use in 2nd line regimen ongoing at screening | n (%) | 174 (61%) | 108 (70%) | 59 (84%) | 27 (79%) | 368 (68%) |
| TDF use in initial 1st line regimen and in 2nd line regimen ongoing at screening | n (%) | 14 (5%) | 6 (4%) | 0 (0%) | 3 (9%) | 23 (4%) |
IQR is defined as the inter-quartile range and displays the 1st and 3rd quartiles, respectively. Baseline was defined as the last evaluation on or before the date of study entry. Summaries of ARV drug exposure were derived using data collected during the screening period.