Table 1.
Baseline Characteristics of Infants Enrolled in the Trial.*
| Variable | Early Antiretroviral Therapy (N = 252) |
Deferred Antiretroviral Therapy (N = 125) |
Total (N = 377) |
|---|---|---|---|
| Female sex — no. (%) | 147 (58.3) | 74 (59.2) | 221 (58.6) |
| Age — wk | |||
| Median | 7.4 | 7.1 | 7.4 |
| Interquartile range | 6.6 to 8.9 | 6.4 to 8.9 | 6.6 to 8.9 |
| Maternal antiretroviral therapy for prevention of mother-to-child transmission of HIV-1 — no. (%) | |||
| No therapy | 26 (10.3) | 15 (12.0) | 41 (10.9) |
| Nevirapine | 162 (64.3) | 72 (57.6) | 234 (62.1) |
| Zidovudine | 8 (3.2) | 5 (4.0) | 13 (3.4) |
| Zidovudine plus nevirapine | 51 (20.2) | 26 (20.8) | 77 (20.4) |
| Maternal therapy with highly active antiretroviral therapy — no. (%) | 2 (0.8) | 5 (4.0) | 7 (1.9) |
| Infant antiretroviral therapy for prevention of mother-to-child transmission of HIV-1 — no. (%) | |||
| No therapy | 40 (15.9) | 20 (16.0) | 60 (15.9) |
| Nevirapine | 124 (49.2) | 68 (54.4) | 192 (50.9) |
| Zidovudine | 5 (2.0) | 1 (0.8) | 6 (1.6) |
| Zidovudine plus nevirapine | 69 (27.4) | 34 (27.2) | 103 (27.3) |
| Breast-fed infants — no. (%) | 35 (13.9) | 19 (15.2) | 54 (14.3) |
| Weight — kg | |||
| Median | 4.4 | 4.5 | 4.4 |
| Interquartile range | 4.0 to 4.9 | 4.0 to 5.0 | 4.0 to 4.9 |
| Weight for age — z score | |||
| Median | −0.8 | −0.5 | −0.7 |
| Interquartile range | −1.5 to 0.0 | −1.4 to 0.2 | −1.5 to 0.0 |
| Weight for length — z score | |||
| Median | 0.3 | 0.3 | 0.3 |
| Interquartile range | 0.2 to 0.3 | 0.2 to 0.3 | 0.2 to 0.3 |
| Head circumference for age — z score | |||
| Median | −0.1 | 0.0 | −0.0 |
| Interquartile range | −0.9 to 0.6 | −0.7 to 0.6 | −0.8 to 0.6 |
| CDC class — no. (%)† | |||
| N and A | 237 (94.0) | 121 (96.8) | 358 (95.0) |
| B | 11 (4.4) | 3 (2.4) | 14 (3.7) |
| CD4 percentage | |||
| Median | 35.1 | 35.6 | 35.2 |
| Interquartile range | 29.1 to 40.8 | 29.1 to 43.8 | 29.1 to 41.2 |
| CD4 cell count — per mm3 | |||
| Median | 2035 | 2044 | 2039 |
| Interquartile range | 1519 to 2754 | 1585 to 2960 | 1541 to 2789 |
| Hemoglobin — g/dl | |||
| Median | 10.1 | 10.2 | 10.1 |
| Interquartile range | 9.3 to 10.7 | 9.4 to 11 | 9.4 to 10.8 |
| Total lymphocyte count — per mm3 | |||
| Median | 6065 | 6250 | 6110 |
| Interquartile range | 4510 to 7735 | 4450 to 7500 | 4490 to 7690 |
| Plasma HIV-1 RNA — log10 copies/ml | |||
| Median | 5.9 | 5.9 | 5.9 |
| Interquartile range | 5.6 to 5.9 | 5.6 to 5.9 | 5.6 to 5.9 |
*
Information was missing for four infants in the early-therapy group and one infant in the deferred-therapy group.
†
The Centers for Disease Control and Prevention (CDC) classification system is for HIV infection in children younger than 13 years of age.