Table 3.
Risk Factors of Infant HIV-1 Infection and a Composite Outcome of HIV-1 Infection or Death by 28 Weeks Among Infants Who Were HIV-1 Uninfected at Birth
| Risk Factor | Unadjusteda |
Adjustedb |
||
|---|---|---|---|---|
| Hazard Ratio (95% CI) | P Value | Hazard Ratio (95% CI) | P Value | |
| For HIV-1 infection by 28 wk | ||||
| Infant NVP 6 wk vs control | .80 (.53–1.20) | .27 | .80 (.53–1.21) | .29 |
| Infant NVP 14 wk vs control | .39 (.24–.61) | <.001 | .36 (.23–.57) | <.001 |
| Infant NVP + AZT 14 wk vs control | .50 (.33–.77) | .001c | .49 (.32–.75) | .001c |
| Infant NVP 28 wk vs control | .29 (.15–.56) | <.001 | .28 (.15–.54) | <.001 |
| Maternal baseline CD4 count (<350 vs ≥350 cells/μL) | 2.14 (1.68–2.74) | <.001 | 2.19 (1.71–2.80) | <.001 |
| Infant birth weight (per increase of 1 kg) | .65 (.49–.86) | .002 | .64 (.48–.85) | .002 |
| For HIV-1 infection or death by 28 wk | ||||
| Infant NVP 6 wk vs control | .73 (.50–1.06) | .10 | .73 (.50–1.07) | .10 |
| Infant NVP 14 wk vs control | .49 (.34–.71) | <.001 | .46 (.32–.67) | <.001 |
| Infant NVP + AZT 14 wk vs control | .61 (.43–.86) | .005c | .59 (.42–.84) | .003c |
| Infant NVP 28 wk vs control | .39 (.23–.65) | <.001 | .38 (.23–.64) | <.001 |
| Maternal baseline CD4 count (<350 vs ≥350 cells/μL) | 1.83 (1.48–2.27) | <.001 | 1.83 (1.50–2.30) | <.001 |
| Infant birth weight (per increase of 1 kg) | .61 (.49–.78) | <.001 | .60 (.47–.77) | <.001 |
Abbreviations: AZT, zidovudine; BAN, Breastfeeding, Antiretrovirals and Nutrition study; CI, confidence interval; HIV-1, human immunodeficiency virus type 1; NVP, nevirapine; PEPI, Post-Exposure Prophylaxis of the Infant study; SWEN, Six-Week Extended Nevirapine study.
a Proportional hazards models with each risk factor as the sole covariate, stratified by trial site. Infant NVP 6 weeks vs control using SWEN data only, stratified by trial site; infant NVP 14 weeks vs control and infant NPV + AZT 14 weeks vs control using PEPI data only; infant NVP 28 weeks vs control using BAN data only.
b Proportional hazards models adjusted for all variables listed, stratified by trial site.
c Test for proportional hazards assumption 0.025 <P < .05 for all models with infant NPV + AZT; for all other covariates and models P > .05.