Table 1. Characteristics of the patients at baseline, according to randomization arm.
| Study Arm | VL Arm | CD4 Arm | Total |
| Total randomized patientsa | 356 | 360 | 716 |
| Sex: Females (%) | 207 (58%) | 239 (66%) | 446 (62%) |
| Median age – y (IQR) | 35.4 (31.0–41.2) | 36.2 (31.4–41.4) | 35.7 (31.2–41.2) |
| Median BMI (IQR) | 20.7 (18.8–23.0) | 20.9 (19.0–22.9) | 20.8 (19.0–23.0) |
| Median absolute CD4 count – cells/mm3 (IQR) | 146 (90–201) | 144 (90–198) | 144 (90–199) |
| Median VL at enrolment – log10 copies per ml (IQR) | 4.9 (4.3–5.2) | 4.8 (4.3–5.2) | 4.8 (4.3–5.2) |
| CDC stage – n (%) | |||
| B | 83 (23%) | 90 (25%) | 173 (24%) |
| C | 74 (21%) | 64 (18%) | 138 (19%) |
| First-line regimen – n (%) | |||
| Nevirapine-based | 119 (33.4%) | 131 (36.4%) | 250 (35.0%) |
| Efavirenz-based | 236 (66.3%) | 229 (63.6%) | 465 (64.9%) |
| Includes tenofovir | 235 (66.0%) | 238 (66.1%) | 473 (66.1%) |
| Laboratory – median (IQR) | |||
| Hemoglobin – g/dl | 12.0 (10.9–13.3) | 11.8 (10.7–13.0) | 12.0 (10.8 13.1) |
| Alanine aminotransferase – U/L | 28.0 (17.5–42.0) | 28.0 (18.0–40.0) | 28.0 (18.0–41.5) |
| Creatinine – mg/dl | 0.8 (0.7–1.0) | 0.8 (0.7–0.9) | 0.8 (0.7–0.9) |
| Total bilirubin — mg/dl | 0.5 (0.4–0.7) | 0.5 (0.4–0.6) | 0.5 (0.4–0.6) |
| Triglycerides —mg/dl | 129 (95–182) | 130.0 (95–183) | 130 (95–183) |
| Cholesterol — mg/dl | 158 (135–180) | 157 (136–184) | 158 (135–183) |
a
There were eight protocol deviations reported related to inclusion criteria: One patient was not ARV naive, one woman was pregnant, one was chronically infected with hepatitis C, two had hemoglobin level <8.0 g/dl, two had absolute neutrophil count <1,000 cells/mm3, one had serum creatinine above 1.0× ULN.