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Demographic characteristics (ITT exposed population)a and disposition |
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| FPV/r 1400/100 mg + TDF/FTC QD N = 53 |
ATV/r 300/100 mg + TDF/FTC N = 53 |
Total N = 106 |
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| Gender, n (%) |
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| Male |
42 (79%) |
47 (89%) |
89 (84%) |
| Female |
11 (21%) |
6 (11%) |
17 (16%) |
| Age, y |
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| Median (range) |
40 (22–64) |
40 (20–58) |
40 (20–64) |
| Race, n (%)b |
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| White |
34 (64%) |
26 (49%) |
59 (56%) |
| Black |
18 (34%) |
24 (45%) |
42 (40%) |
| Asian |
0 |
1 (2%) |
1 (<1%) |
| Other |
1 (2%) |
2 (4%) |
2 (2%) |
| HIV-1 RNA, log10 copies/mL |
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| Median (range) |
4.924 (2.775–6.320) |
4.890 (3.167–6.362) |
4.907 (2.775–6.362) |
| HIV-1 RNA < 100,000 copies/mL |
29 (55%) |
29 (55%) |
58 (55%) |
| HIV-1 RNA ≥ 100,000 copies/mL |
24 (45%) |
24 (45%) |
48 (45%) |
| CD4+ cell count, cells/mm3 |
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| Median (range) |
161 (19–524) |
188 (19–488) |
171 (19–524) |
| CDC classification, n (%) |
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| Class A (asymptomatic) |
30 (57%) |
34 (64%) |
64 (60%) |
| Class B (symptomatic, non-AIDS) |
14 (26%) |
8 (15%) |
22 (21%) |
| Class C (AIDS) |
9 (17%) |
11 (21%) |
20 (19%) |
| Mean GFR (by MDRD), mL/min/1.73 m2 |
87.7 (± 20.4) |
90.6 (± 18.0) |
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| Study Withdrawals |
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| Completed |
45 (85%) |
49 (92%) |
94 (89%) |
| Prematurely withdrawn |
8 (15%) |
4 (8%) |
12 (11%) |
| Reason for premature withdrawal |
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| Adverse event |
1 (2%) |
1 (2%) |
2 (2%) |
| Lost to follow-up |
2 (4%) |
0 |
2 (2%) |
| Protocol violation |
1 (2%) |
0 |
1 (<1%) |
| Protocol-defined virologic failure |
4 (8%) |
3 (6%) |
7 (7%) |
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aComprised all patients exposed to ≥ 1 dose of randomized study medication. b12 patients in the FPV/r arm and 12 in the ATV/r arm were of Hispanic/Latino ethnicity. | |||
Smith et al. AIDS Research and Therapy 2008 5:5 doi:10.1186/1742-6405-5-5 |
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