TABLE 1.
Baseline characteristics of subjects enrolled in the EPIC and ASCENT studies
| Baseline characteristic | EPIC
|
ASCENT
|
||
|---|---|---|---|---|
| APL + LPV-RTV (n = 165)a | ZDV-3TC + LPV-RTV (n = 26) | APL + ZDV-3TC (n = 116)b | EFV + ZDV-3TC (n = 29) | |
| Age category (no. [%] of subjects) | ||||
| <35 yr | 71 (43) | 9 (35) | 35 (30) | 12 (41) |
| ≥35 yr | 94 (57) | 17 (65) | 81 (70) | 17 (59) |
| Gender (no. [%] of subjects) | ||||
| Male | 140 (85) | 23 (88) | 94 (81) | 26 (90) |
| Female | 25 (15) | 3 (12) | 22 (19) | 3 (10) |
| Race | ||||
| African heritage | 25 (15) | 3 (12) | 23 (20) | 7 (24) |
| American Indian or Alaskan | 3 (2) | 0 | 4 (3) | 1 (3) |
| Asian | 2 (1) | 1 (4) | 1 (1) | 0 |
| Japanese/East Asian | 2 (1) | 1 (4) | 1 (1) | 0 |
| Pacific Islander | 1 (<1) | 0 | 0 | 0 |
| White | 130 (79) | 21 (84) | 88 (76) | 21 (72) |
| Missing | 2 (1) | 0 | 0 | 0 |
| Ethnicity | ||||
| Hispanic or Latino | 31 (19) | 5 (19) | 21 (18) | 10 (34) |
| Not Hispanic or Latino | 134 (81) | 21 (81) | 95 (82) | 19 (66) |
| Baseline mean (range) log10 no. of plasma HIV-1 RNA copies/ml | 5.2 (3.8-6.3) | 5.2 (4.6-6.1) | 5.0 (4.0-6.6) | 5.1 (3.8-6.2) |
| Baseline mean (range) CD4+ cell count (no. of cells/mm3) | 277 (56-821) | 299 (95-529) | 261 (87-663) | 292 (133-633) |
| CDC classification (no. [%] of subjects) | ||||
| Class A | 141 (85) | 21 (81) | 93 (80) | 23 (79) |
| Class B | 20 (12) | 3 (12) | 17 (15) | 2 (7) |
| Class C | 4 (2) | 1 (4) | 6 (5) | 4 (14) |
| Missing | 0 | 2 (8) | 0 | 0 |
| No. (%) of subjects) with the following hepatitis B virus/hepatitis C virus infection statusc: | ||||
| Negative/negative | 142 (86) | 23 (88) | 106 (91) | 25 (86) |
| Positive/negative | 3 (2) | 1 (4) | 3 (3) | 2 (7) |
| Negative/positive | 16 (10) | 0 | 5 (4) | 2 (7) |
| Positive/positive | 1 (<1) | 1 (4) | 0 | 0 |
| Missing | 3 (2) | 1 (4) | 2 (2) | 0 |
a
All APL arms combined; APL 200 mg BID (n = 54), APL 400 mg BID (n = 56), and APL 800 mg QD (n = 55).
b
All APL arms combined: APL 600 mg BID (n = 58) and APL 800 mg BID (n = 58).
c
Positive or negative for hepatitis B virus surface antigen and positive or negative for hepatitis C antibody at the baseline.