Table 1.
Pretreatment characteristics of study sample by renal abnormalities during study follow-up
| Characteristics | Renal abnormality
|
Total (N = 1,045) | P | |
|---|---|---|---|---|
| No (n = 1,024) | Yes (n = 21) | |||
| Randomized treatment arm, n (%)a | ||||
| ZDV/3TC + EFV | 513 (50) | 6 (29) | 519 (50) | .08b |
| TDF/FTC + EFV | 511 (50) | 15 (71) | 526 (50) | |
| Age, years, median (IQR) | 34 (29–40) | 41 (32–46) | 34 (29–41) | .006c |
| Sex, n (%) | ||||
| Female | 474 (46) | 9 (43) | 483 (46) | .83b |
| Male | 550 (54) | 12 (57) | 562 (54) | |
| Country strata, n (%) | ||||
| Brazil | 154 (15) | 1 (5) | 155 (15) | .07d |
| Haiti | 67 (7) | 1 (5) | 68 (7) | |
| India | 164 (16) | 5 (24) | 169 (16) | |
| Malawi | 139 (14) | 8 (38) | 147 (14) | |
| Peru | 86 (8) | 0 (0) | 86 (8) | |
| South Africa | 139 (14) | 1 (5) | 140 (13) | |
| Thailand | 66 (6) | 1 (5) | 67 (6) | |
| United States | 138 (13) | 2 (10) | 140 (13) | |
| Zimbabwe | 71 (7) | 2 (10) | 73 (7) | |
| Body mass index, kg/m2, median (IQR) | 22.5 (20.2–25.2) | 21.6 (18.9–24.4) | 22.4 (20.2–25.2) | .28c |
| Screening CD4 cell count, cells/μL, median (IQR) | 167 (89–229) | 145 (75–215) | 167 (89–228) | .46 c |
| Plasma HIV-1 viral load, log10 copies/mL, median (IQR) | 5.0 (4.6–5.4) | 5.3 (4.7–5.5) | 5.0 (4.6–5.4) | .24 c |
| History of AIDS related diagnoses, n (%) | ||||
| No | 916 (89) | 16 (76) | 932 (89) | .07b |
| Yes | 108 (11) | 5 (24) | 113 (11) | |
| History of tuberculosis, n (%) | ||||
| No | 838 (32) | 15 (71) | 853 (82) | .25 b |
| Yes | 186 (18) | 6 (29) | 192 (18) | |
| History of hypertension, n (%) | ||||
| No | 967 (94) | 19 (90) | 986 (94) | .34 b |
| Yes | 57 (6) | 2 (10) | 59 (6) | |
| History of diabetes, n (%) | ||||
| No | 1014 (99) | 19 (91) | 1,033 (99) | <.001d |
| Yes | 10 (1) | 2 (9) | 12 (1) | |
| Creatinine clearance by CG, mL/min, median (IQR)e | 99.0 (81.6–121.1) | 77.4 (67.5–92.0) | 98.3 (80.9–120.9) | <.001c |
| Abnormal urine dipstick, n (%)f | ||||
| No | 935 (91) | 16 (76) | 951 (91) | .17b |
| Yes | 39 (4) | 2 (10) | 41 (4) | |
| Missing | 50 (5) | 3 (14) | 53 (5) | |
Note: CG = Crockoft-Gault; ZDV = zidovudine; 3TC = lamivudine; EFV = efavirenz; TDF = tenofovir; FTC = emtricitabine; IQR = interquartile range.
a
Percentages are column percentages.
b
Fisher’s exact test.
c
Exact Wilcoxon test.
d
Chi-square test.
e
A total of 11 missing values (all in the “no” renal abnormality group).
f
Urine dipsticks positive for protein ≥ 2+or glucose ≥ 1+.