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Table 1 Characteristics and disposition of the study patients (intent-to-treat population)

From: Substituting abacavir for hyperlipidemia-associated protease inhibitors in HAART regimens improves fasting lipid profiles, maintains virologic suppression, and simplifies treatment

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   Consent withdrawn 0 9 (17) 9 (9)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)
  1. *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.
  2. 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.