Table 3. Primary outcomes (clinical failure) at 3 y: death, new AIDS-defining events, or confirmed CD4 <50/mm3.
Clinical Failure (Death, New AIDS-Defining Event, CD4 <50/mm3) | VLn = 356 | CD4n = 360 | p-Value |
Kaplan Meier Risk (95% CI) | 8.0% (5.6–11.4) | 7.4% (5.1–10.7)a | 0.74 |
Rate per 100 patient years (95% CI) | 2.5 (1.8–3.6) | 2.3 (1.6–3.4) | 0.76 |
Death | |||
Kaplan Meier risk (95% CI) | 4.3% (2.6–7.1) | 3.4% (2.0–6.0) | 0.57 |
Mortality rate per 100 patient years (95% CI) | 1.4 (0.8–2.2) | 1.1 (0.7–1.9) | 0.74 |
The 95% CI of the difference, −0.6% was −4.5% to 3.4%. The upper limit of this CI was below the pre-determined criterion for non-inferiority, 7.4%.