Table 1. Baseline demographic and clinical characteristics of 812 subjects randomised to doctor or nurse monitored antiretroviral therapy in the CIPRA-SA trial in South Africa.
| Nurse Arm | Doctor Arm | RR (95% CI) or pvalue** | |
|---|---|---|---|
| (N=404) | (N=408) | ||
| Female | 297 (73.5%) | 276 (67.7%) | 1.16 (0.99-1.36) |
| Age years median (IQR) | 32.3 (28.0-36.6) | 32.2 (28.0-37.4) | 0.8344 |
| BMI (kg/m2) (IQR) | 23.5 (21.3-27.6) | 23.5 (20.4-26.8) | 0.1044 |
| CDC Classification | |||
| Class A (%) | 160 (39.6%) | 141 (34.6%) | Reference |
| Class B (%) | 111 (27.5%) | 118 (28.9%) | 0.91 (0.77-1.08) |
| Class C (%) | 133 (32.9%) | 149 (36.5%) | 0.89 (0.75-1.04) |
| CD4+ Count (cells/ml) | |||
| <200 (%) | 260 (64.4%) | 257 (63.0%) | |
| 200-350 (%) | 119 (29.5%) | 131 (32.1%) | 0.95 (0.81-1.11) |
| 350-500 (%) | 23 (5.7%) | 18 (4.4%) | 1.12 (0.84-1.48) |
| > 500 (%) | 2 (0.5%) | 2 (0.5%) | 0.99 (0.37-2.66) |
| Median (IQR) | 165 (105-235) | 164 (110-225) | 0.7042 |
| Viral load (copies/ml) | |||
| ≤ 100,000 (%) | 181 (44.8%) | 170 (41.7%) | Reference |
| > 100,000 (%) | 223 (55.2%) | 238 (58.3%) | 0.94 (0.82-1.08) |
| Log10 mean viral load (std) | 4.99 (0.75) | 5.09 (0.73) | 0.939 |
| Baseline regimen prescribed | |||
| Stavudine, Lamivudine, Efavirenz | 293 (72.5%) | 304 (74.5%) | Reference |
| Stavudine, Lamivudine, Nevirapine | 72 (17.8%) | 81 (19.9%) | 0.96 (0.8-1.16) |
| Stavudine, Lamivudine, Lopinavir/rtv † | 35 (8.7%) | 20 (4.9%) | 1.30 (1.04-1.61) |
| Stavudine, Lamivudine, Nelfinavir‡ | 4 (1%) | 3 (0.7%) | 1.16 (0.61-2.22) |
| Prior exposure to antiretrovirals* | |||
| Single Dose Nevirapine (%) | 81 (20%) | 86 (21.1%) | Reference |
| Zidovudine (%) | 2 (0.5%) | 4 (1.0%) | 0.69 (0.22-2.15) |
| Nevirapine, Zidovudine (%) | 14 (3.5%) | 15 (3.7%) | 1.00 (0.66-1.5) |
| Triple drug therapy (%) | 1 (0.2%) | 0 (0%) | 2.06 (1.76-2.41) |
† ‡
Protease inhibitor containing regimens were prescribed to pregnant women or women of childbearing potential with CD4+ count >250 who were unable or unwilling to use both a barrier contraceptive and a progesterone contraceptive. These women could not receive either a Nevirapine or Efavirenz containing regimen
*
Prior exposure to antiretroviral therapy for prevention of transmission, either from mother-to-child or in post-sexual exposure prophylaxis was permitted by the protocol for up to 6 weeks of treatment.
**
pvalue is from a Kalmogorov-Smirnoff test. RR = relative risk, CI = Confidence interval. RR is a row relative risk.