Characteristic | Abacavir-switch arm (N = 52) | PI-continuation arm (N = 52) | Total study population (N = 104) |
---|---|---|---|
Age, y | |||
Median (range) | 43 (23–64) | 42 (25–62) | 42 (23–64) |
Sex, No. (%) | |||
Male | 46 (88) | 47 (90) | 93 (89) |
Female | 6 (12) | 5 (10) | 11 (11) |
Race, No. (%) | |||
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 (%) | |||
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) | |
Mean (SD) LDL cholesterol, mg/dL | 149 (34) | 149 (30) | |
Mean (SD) HDL cholesterol, mg/dL | 39 (15) | 42 (14) | |
Mean (SD) triglycerides, mg/dL | 340 (213) | 280 (282) | |
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 (%) | |||
Any | 28 (56) | 20 (44) | 48 (46) |
NRTIs | |||
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 | |||
Efavirenz | 1 (2) | 0 | |
PIs | |||
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 | |||
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Consent withdrawn | 0 | 9 (17) | 9 (9) |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) |