Table 2.
Characteristics of the Patients, According to the Timing of Initiation of Antiretroviral Therapy and CD4+ Count at Baseline.*
| Variable | 351-to-500 CD4+ Count | More-Than-500 CD4+ Count | ||
|---|---|---|---|---|
| Early-Therapy Group | Deferred-Therapy Group | Early-Therapy Group | Deferred-Therapy Group | |
| No. of patients | 2084 | 6,278 | 2220 | 6,935 |
| Follow-up person-years (no.) | 8353 | 15,624 | 8663 | 17,776 |
| Deaths within 1 yr after last CD4+ count (no.) | 137 | 238 | 113 | 198 |
| Age (yr) | ||||
| Median | 40 | 38 | 40 | 38 |
| Interquartile range | 34–48 | 32–45 | 33–48 | 32–45 |
| Male sex (%) | 84 | 75 | 82 | 73 |
| Race (%)† | ||||
| White | 45 | 40 | 49 | 42 |
| Black | 38 | 44 | 36 | 44 |
| Other | 17 | 16 | 15 | 14 |
| CD4+ count at baseline (cells/mm3) | ||||
| Median | 422 | 431 | 679 | 664 |
| Interquartile range | 387–460 | 391–468 | 580–840 | 573–811 |
| HIV RNA at baseline (log10 copies/ml)‡ | ||||
| Median | 4.2 | 4.1 | 3.5 | 3.7 |
| Interquartile range | 2.9–4.9 | 3.4–4.6 | 2.6–4.6 | 2.7–4.4 |
| Hepatitis C virus infection (%)§ | 27 | 33 | 25 | 35 |
| History of injection-drug use (%)¶ | 15 | 20 | 14 | 21 |
| No. of patients who initiated antiretroviral therapy | 2084 | 803 | 2220 | 539 |
| Year of initiation of antiretroviral therapy | ||||
| Median | 2000 | 2001 | 2000 | 2000 |
| Interquartile range | 1998–2001 | 1998–2003 | 1998–2001 | 1998–2003 |
| Interval from first CD4+ count to initiation of antiretroviral therapy (mo) | ||||
| Median | 3 | 3 | 2 | 3 |
| Interquartile range | 2–3 | 2–4 | 2–3 | 2–4 |
| CD4+ count at initiation of antiretroviral therapy (cells/mm3) | ||||
| Median | 422 | 286 | 679 | 410 |
| Interquartile range | 387–460 | 228–320 | 580–840 | 332–464 |
| Type of first antiretroviral therapy (%) | ||||
| Protease inhibitor–based | ||||
| Without boost | 48 | 40 | 50 | 43 |
| With boost | 9 | 11 | 7 | 9 |
| Nonnucleoside reverse-transcriptase inhibitor–based | 33 | 38 | 32 | 38 |
| Protease inhibitor and nonnucleoside reverse-transcriptase inhibitor–based | 4 | 2 | 4 | 3 |
| ≥3 Nucleoside reverse-transcriptase inhibitors | 6 | 9 | 6 | 8 |
| HIV RNA <500 copies/ml within 12 mo after initiation of antiretroviral therapy (%) | 75 | 72 | 81 | 71 |
The CD4+ count was measured in cells per cubic millimeter. P<0.05 for all comparisons between the early-therapy group and the deferred-therapy group except for the response to the initiation of antiretroviral therapy in the number of HIV RNA copies in patients with a 351-to-500 CD4+ count (P = 0.16) and the median year of initiation of antiretroviral therapy in patients with a more-than-500 CD4+ count (P = 0.72). HIV denotes human immunodeficiency virus.
Race was self-reported. Race was evaluated in 7657 patients with a CD4+ count of 351 to 500 cells per cubic millimeter and in 8462 patients with a CD4+ count of more than 500 cells per cubic millimeter.
Baseline HIV RNA levels were evaluated in 6425 patients with a CD4+ count of 351 to 500 cells per cubic millimeter and in 6566 patients with a CD4+ count of more than 500 cells per cubic millimeter.
The status of hepatitis C virus infection was evaluated in 4404 patients with a CD4+ count of 351 to 500 cells per cubic millimeter and in 5147 patients with a CD4+ count of more than 500 cells per cubic millimeter. Data on hepatitis C virus infection were not obtained for two cohorts of patients.
The status of injection-drug use was evaluated in 5744 patients with a CD4+ count of 351 to 500 cells per cubic millimeter and in 6087 patients with a CD4+ count of more than 500 cells per cubic millimeter. The use of injection drugs was not evaluated for one cohort.