Sebikari D, et al. - Considering the multicountry PROMISE 1077BF/1077FF trial demonstrating significantly higher risk of low birth weight (LBW; <2500 g) and preterm delivery (PTD; <37 weeks) among women initiating a protease inhibitor–based antiretroviral treatment (ART) regimen than those receiving ZDV alone and that a protease inhibitor regimen, tenofovir/emtricitabine vs zidovudine/lamivudine, was associated with the more severe outcomes of very LBW (<1500 g) and very PTD (<34 weeks), researchers further explored these treatment findings, taking into account demographic baseline clinical and postentry obstetrical factors using multivariate logistic regression. Individual adverse outcomes and composites that included stillbirth and early loss/spontaneous abortion were evaluated among 3333 women delivering at least 1 live infant [median maternal age at enrollment: 26 years; 661 (20%) primiparous; 110 (3.3%) had at least 1 previous PTD]. Findings revealed that even after controlling for demographic, baseline clinical, and obstetrical risk factors, which were also associated with adverse pregnancy outcomes reported in the randomized PROMISE trial, ART effects on these outcomes remained strongly significant.