Table 1.
Entry Participant Characteristics by Sex
| Variable | Description | Sex |
p- value* |
|
|---|---|---|---|---|
| Female (n=739) | Male (n=832) | |||
| Age, years† | 33 (30, 41) | 35 (28, 39) | <0.001 | |
| Race (%) | Asian | 166 (22.5%) | 192 (23.1%) | <0.001 |
| Black/ African American | 458 (62.0%) | 329 (39.5%) | ||
| White | 58 (7.8%) | 193 (23.2%) | ||
| Other/unknown | 57 (7.7%) | 118 (14.2%) | ||
| Ethnicity (%) | Hispanic | 90 (12.2%) | 232 (27.9%) | <0.001 |
| Site location; country (%) | Brazil | 82 (11.1%) | 149 (17.9%) | <0.001 |
| Haiti | 48 (6.5%) | 52 (6.3%) | ||
| India | 111 (15.0%) | 144 (17.3%) | ||
| Malawi | 149 (20.2%) | 72 (8.7%) | ||
| Peru | 45 (6.1%) | 89 (10.7%) | ||
| South Africa | 141 (19.4%) | 69 (8.3%) | ||
| Thailand | 55 (7.4%) | 45 (5.4%) | ||
| United States | 38 (5.1%) | 172 (20.7%) | ||
| Zimbabwe | 70 (9.5%) | 40 (4.8%) | ||
| Weight; kg‡ | 58.5 (13.3) | 66.3 (13.6) | <0.001 | |
| Body mass index ;kg/m2‡ | 23.6 (5.0) | 22.7 (3.7) | 0.002 | |
| Anthropometric measurements† | Mid arm (cm) | 27.2 (25.0, 30.0) | 27.8 (25.7, 30.0) | 0.013 |
| Mid thigh (cm) | 48.0 (44.0, 53.2) | 46.5 (43.0, 50.6) | <0.001 | |
| Waist/hip ratio | 0.8 (0.8, 0.9) | 0.9 (0.9, 0.9) | <0.001 | |
| Karnofsky Score Median | 90 (90, 100) | 90 (90, 100) | 0.080 | |
| Any prior/current binge drinking | 80 (10.8%) | 249 (29.9%) | <0.001 | |
| CD4+ lymphocyte count (mm−3)† | 182 (113, 232) | 165 (81, 230) | <0.001 | |
| Plasma HIV-1 RNA (log10copies/mL)† | 4.9 (4.5, 5.4) | 5.2 (4.7, 5.5) | <0.001 | |
| Screening plasma HIV RNA stratum | < 100,000 c/mL | 382 (51.7%) | 339 (40.7%) | <0.001 |
| > 100,000 c/mL | 357 (48.3%) | 493 (59.3%) | ||
| Prior or current AIDS diagnosis | 46 (6.6%) | 121 (14.5%) | <0.001 | |
| Prior or current tuberculosis | 129 (17.2%) | 150 (17.6%) | 0.690 | |
| Hepatitis B surface antigen positive | 35 (4.7%) | 55 (6.6%) | 0.110 | |
| Liver transaminases† | AST, IU/L | 28 (23, 38) | 31 (24, 41) | <0.001 |
| ALT, IU/L | 22 (16, 32) | 29 (20, 45) | <0.001 | |
| Creatinine clearance, mL/min†,‖ | 94 (78, 117) | 101 (84, 123) | <0.001 | |
| Randomized treatment assignment§ | EFV+3TC/ZDV | 241 (32.6%) | 278 (33.4%) | 0.65 |
| ATV+FTC+DDI-EC | 256 (34.6%) | 270 (32.5%) | ||
| EFV+FTC/TDF | 242 (32.7%) | 284 (34.1%) | ||
*
Wilcoxon Rank Sum test for continuous variables; Chi-square test for categorical variables.
†
Median (25th and 75th percentiles)
‡
Mean (standard deviation)
§
Antiretroviral drugs were: Efavirenz (EFV), lamivudine (3TC), zidovudine (ZDV), atazanavir (ATV), emtricitabine (FTC) and tenofovir-DF (TDF).
‖
Crockoft-Gault calculation.