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Characteristics and disposition of the study patients (intent-to-treat population) |
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| Characteristic |
Abacavir-switch arm (N = 52) |
PI-continuation arm (N = 52) |
Total study population (N = 104) |
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| Age, y |
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| Median (range) |
43 (23–64) |
42 (25–62) |
42 (23–64) |
| Sex, No. (%) |
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| Male |
46 (88) |
47 (90) |
93 (89) |
| Female |
6 (12) |
5 (10) |
11 (11) |
| Race, No. (%) |
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| Caucasian |
26 (50) |
28 (54) |
54 (52) |
| African American |
16 (31) |
11 (21) |
27 (26) |
| Hispanic |
10 (19) |
13 (25) |
23 (22) |
| Mean HIV-1 RNA, log10 copies/mL (SD) |
1.73 (0.16) |
1.69 (0.04) |
1.71 (0.06) |
| Mean CD4+ cell count, cells/mm3 (SD) |
551 (226) |
531 (233) |
541 (229) |
| Mean weight, kg (SD) |
79.3 (16.8) |
80.4 (16.6) |
79.8 (16.7) |
| Mean BMI, kg/cm2 (SD) |
25.9 (4.5) |
26.4 (4.9) |
26.1 (4.7) |
| Mean waist-to-hip ratio |
0.94 (0.06) |
0.93 (0.07) |
0.94 (0.06) |
| CDC Class, n (%) |
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| Category A |
33 (63) |
34 (65) |
67 (64) |
| Category B |
10 (19) |
11 (21) |
21 (20) |
| Category C |
9 (17) |
7 (13) |
16 (15) |
| Mean (SD) total cholesterol, mg/dL |
244 (45) |
241 (44) |
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| Mean (SD) LDL cholesterol, mg/dL |
149 (34) |
149 (30) |
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| Mean (SD) HDL cholesterol, mg/dL |
39 (15) |
42 (14) |
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| Mean (SD) triglycerides, mg/dL |
340 (213) |
280 (282) |
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| Coronary artery disease risk factors, n (%)* |
34 (65) |
26 (50) |
60 (58) |
| Age |
18 (35) |
12 (23) |
30 (29) |
| Family history |
4 (8) |
4 (8) |
8 (8) |
| Cigarette smoking |
19 (37) |
13 (25) |
32 (31) |
| Hypertension |
5 (10) |
8 (15) |
13 (13) |
| Low HDL |
10 (19) |
4 (8) |
14 (13) |
| Diabetes mellitus |
3 (6) |
0 |
3 (3) |
| Antiretroviral medications taken prior to screening, n (%) |
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| Any |
28 (56) |
20 (44) |
48 (46) |
| NRTIs |
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| Zidovudine |
16 (32) |
9 (20) |
25 (24) |
| Lamivudine |
12 (24) |
8 (18) |
20 (19) |
| Stavudine |
5 (10) |
2 (4) |
7 (7) |
| Didanosine |
7 (14) |
0 |
7 (7) |
| Zalcitabine |
3 (6) |
0 |
3 (3) |
| NNRTIs |
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| Efavirenz |
1 (2) |
0 |
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| PIs |
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| Indinavir |
11 (22) |
8 (18) |
19 (18) |
| Nelfinavir |
4 (8) |
2 (4) |
6 (6) |
| Ritonavir |
2 (4) |
1 (2) |
3 (3) |
| Saquinavir |
2 (4) |
0 |
2 (2) |
| PI used at screening |
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| Nelfinavir |
22 (42) |
21 (40) |
43 (41) |
| Indinavir |
21 (40) |
22 (42) |
43 (41) |
| Saquinavir SGC |
6 (12) |
6 (12) |
12 (12) |
| Amprenavir |
2 (4) |
2 (4) |
4 (4) |
| Ritonavir |
1 (2) |
1 (2) |
2 (2) |
| Premature withdrawal from study, n (%) |
14 (27) |
11 (21) |
25 (24) |
| Adverse event |
7 (13) |
1 (2) |
8 (8) |
| Consent withdrawn |
0 |
9 (17) |
9 (9) |
| Lost to follow-up |
1 (2) |
1 (2) |
2 (2) |
| Protocol violation |
2 (4) |
0 |
2 (2) |
| Protocol-defined virologic failure |
3 (6) |
0 |
3 (3) |
| Other |
1 (2) |
0 |
1 (1) |
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*Cumulative coronary artery disease risk factors in the abacavir-switch arm: 0 factors = 18; 1 factor = 16; 2 factors = 12; 3 factors = 5; 4 factors = 1. Cumulative coronary artery risk factors in the PI-continuation arm: 0 factors = 26; 1 factor = 12; 2 factors = 13; and 3 factors = 1. Abbreviations: AIDS = acquired immune deficiency syndrome; ART = antiretroviral therapy; CDC = Centers for Disease Control; HDL = high density lipoprotein; HIV-1 = human immunodeficiency virus type 1; LDL = low density lipoprotein; LSM = least squares mean; SD = standard deviation; SGC = soft gel capsule. | |||
Keiser et al. BMC Infectious Diseases 2005 5:2 doi:10.1186/1471-2334-5-2 |
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