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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.
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