Table 5.

Protein urine dipstick results over time by treatment arm

Protein by urine dipstick	AZT/3TC/EFV	TDF/FTC/EFV	Total	P valuea
Week 0b
No. of subjects on Step 1c	519	526	1,045
No. of urine specimens collected	497	495	992
Protein - Negative, n (%)d	377 (75.9)	353 (71.3)	730 (73.6)	.10
Trace	52 (10.5)	81 (16.4)	133 (13.4)
1+	46 (9.3)	44 (8.9)	90 (9.1)
2+	14 (2.8)	14 (2.8)	28 (2.8)
3+	6 (1.2)	3 (0.6)	9 (0.9)
4+	1 (0.2)	0 (0)	1 (0.1)
Not evaluated or recorded	1 (0.2)	0 (0)	1 (0.1)
Week 24
No. of subjects on Step 1	497	506	1,003
No. of urine specimens collected	488	490	978
Protein - Negative, n (%)	427 (87.5)	422 (86.1)	849 (86.8)	.28
Trace	33 (6.8)	39 (8.0)	72 (7.4)
1+	20 (4.1)	23 (4.7)	43 (4.4)
2+	7 (1.4)	5 (1.0)	12 (1.2)
3+	1 (0.2)	1 (0.2)	2 (0.2)
4+	0 (0)	0 (0)	0 (0)
Not evaluated or recorded	0 (0)	0 (0)	0 (0)
Week 48
No. of subjects on Step 1	469	474	943
No. of urine specimens collected	461	460	921
Protein - Negative, n (%)	410 (88.9)	403 (87.6)	813 (88.3)	.27
Trace	31 (6.7)	33 (7.2)	64 (6.9)
1+	12 (2.6)	20 (4.3)	32 (3.5)
2+	5 (1.1)	3 (0.7)	8 (0.9)
3+	3 (0.7)	1 (0.2)	4 (0.4)
4+	0 (0)	0 (0)	0 (0)
Not evaluated or recorded	1 (0.2)	0 (0)	0 (0)
Week 72
No. of subjects on Step 1	457	457	914
No. of urine specimens collected	435	443	878
Protein - Negative, n (%)	383 (88.0)	382 (86.2)	765 (87.1)	.28
Trace	30 (6.9)	44 (9.9)	74 (8.4)
1+	16 (3.7)	14 (3.2)	30 (3.4)
2+	5 (1.1)	2 (0.5)	7 (0.8)
3+	1 (0.2)	0 (0)	1 (0.1)
4+	0 (0)	0 (0)	0 (0)
Not evaluated or recorded	0 (0)	1 (0.2)	1 (0.1)
Week 96
No. of subjects on Step 1	446	454	900
No. of urine specimens collected	423	443	866
Protein - Negative, n (%)	372 (87.9)	391 (88.3)	763 (88.1)	.42
Trace	32 (7.6)	36 (8.1)	68 (7.9)
1+	13 (3.1)	15 (3.4)	28 (3.2)
2+	4 (0.9)	1 (0.2)	5 (0.6)
3+	2 (0.5)	0 (0)	2 (0.2)
4+	0 (0)	0 (0)	0 (0)
Not evaluated or recorded	0 (0)	0 (0)	0 (0)
Week 120
No. of subjects on Step 1	425	445	870
No. of urine specimens collected	405	427	832
Protein - Negative, n (%)	347 (85.7)	360 (84.3)	707 (85.0	.24
Trace	42 (10.4)	52 (12.2)	94 (11.3)
1+	11 (2.7)	10 (2.3)	21 (2.5)
2+	2 (0.5)	3 (0.7)	5 (0.6)
3+	1 (0.2)	2 (0.5)	3 (0.4)
4+	0 (0)	0 (0)	0 (0)
Not evaluated or recorded	2 (0.5)	0 (0)	2 (0.2)
Week 144
No. of subjects on Step 1	415	434	849
No. of urine specimens collected	394	414	808
Protein - Negative, n (%)	344 (87.3)	335 (80.9)	679 (84.0)	.008
Trace	29 (7.4)	57 (13.8)	86 (10.6)
1+	12 (3.0)	18 (4.3)	30 (3.7)
2+	6 (1.5)	4 (1.0)	10 (1.2)
3+	2 (0.5)	0 (0)	2 (0.2)
4+	0 (0)	0 (0)	0 (0)
Not evaluated or recorded	1 (0.3)	0 (0)	1 (0.1)
Week 168
No. of subjects on Step 1	342	365	707
No. of urine specimens collected	299	318	617
Protein - Negative, n (%)	262 (87.6)	260 (81.8)	522 (84.6)	.043
Trace	19 (6.4)	37 (11.6)	56 (9.1)
1+	14 (4.7)	16 (5.0)	30 (4.)
2+	2 (0.7)	3 (0.9)	5 (0.8)
3+	1 (0.3)	0 (0)	1 (0.2)
4+	1 (0.3)	0 (0)	1 (0.2)
Not evaluated or recorded	0 (0)	2 (0.6)	2 (0.3)
Week 192
No. of subjects on Step 1	216	228	444
No. of urine specimens collected	156	163	319
Protein - Negative, n (%)	138 (88.5)	136 (83.4)	274 (85.9)	.10
Trace	10 (6.4)	15 (9.2)	25 (7.8)
1+	5 (3.2)	10 (6.1)	15 (4.7)
2+	2 (1.3)	1 (0.6)	3 (0.9)
3+	1 (0.6)	1 (0.6)	2 (0.6)
4+	0 (0)	0 (0)	0 (0)
Not evaluated or recorded	0 (0)	0 (0)	0 (0)

Note: 3TC = lamivudine; EFV = efavirenz; FTC = emtricitabine; TDF = tenofovir; ZDV = zidovudine.

^aBy Wilcoxon test. The level “not evaluated/not reported” is excluded from treatment comparison.

^bWeek 0 is defined as prior to the randomization date. Other weeks are defined as the scheduled time ±28 days.

^cAt randomization for initial study regimen.

^dNegative: <10 mg/dL; Trace: ≥10mg/dL and <30 mg/dL; 1+: ≥30 mg/dL and <100 mg/dL; 2+: ≥100 mg/dL and <300 mg/dL; 3+: ≥300 mg/dL and <1,000 mg/dL; 4+: ≥1,000 mg/dL.