Table 1.
Summary of Patient Characteristics at Baseline (Primary Intent-to-Treat Population)
| Characteristic | Saquinavir-SGC 1600 mg + ritonavir 100 mg, Once Daily (n = 75) | Efavirenz 600 mg Once Daily (n = 77) |
|---|---|---|
| Male n (%) | 53 (71) | 58 (75) |
| Female n (%) | 22 (29) | 19 (25) |
| Race n (%) | ||
| White | 28 (37) | 29 (38) |
| Black | 34 (45) | 38 (49) |
| Hispanic | 6 (8) | 8 (10) |
| Other | 7 (9) | 2 (3) |
| Age (y); mean ± SD (range) | 37.2 ± 9.7 (20-61) | 37.2 ± 9.9 (19-61) |
| Weight (kg); mean ± SD (range) | 78.0 ± 16.5 (52-126) | 75.4 ± 15.0 (44-136) |
| Plasma HIV RNA (log10 copies/mL); mean ± SD (range) | 4.8 ± 0.6 (3.34-6.49) | 4.7 ± 0.5 (3.51-5.66) |
| CD4+ cell count (cells/mcL); mean ± SD (range) | 372 ± 190 (75-1025) | 343 ± 180 (80-900) |
| Nucleoside reverse transcriptase inhibitor combination therapy; n (%) | ||
| 3TC-AZT | 47 (63) | 52 (68) |
| 3TC-d4T | 27 (36) | 22 (29) |
| 3TC-ddI | 0 | 2 (3) |
| AZT-ddI | 1 (1) | 0 |
| d4T-ddI | 0 | 1 (1) |
| Stratification (HIV RNA); n (%) copies/mL | ||
| ≥ 5000-75,000 | 39 (52) | 43 (56) |
| > 75,000 copies/mL | 36 (48) | 34 (44) |
SGC = soft gelatin capsule; SD = standard deviation; 3TC = lamivudine; AZT = zidovudine; d4T = stavudine; ddI = didanosine.