We also measured the malondialdehyde (MDA) concentration in placental tissue, which is one of the end products of lipid peroxidation and an indicator of free radical production and oxidative stress. MDA was spectrophotometrically quantified in tissue

using an assay for material reactive with thiobarbituric acid [18]. The primary endpoint was the difference in infant peripheral blood mtDNA content between the HIV-exposed group and the controls. From previous studies, we expected an mtDNA mean of approximately 193 copies/PBMC with a standard deviation of 97 [7,9,11], and we considered changes of ∼50% in this current study clinically meaningful. Therefore, the sample size estimation was 17 mother–infant pairs per group. Comparisons between HIV-infected and uninfected women and between HIV-exposed and unexposed infants were performed using nonparametric tests. Continuous variables were analysed using

Sotrastaurin price the Wilcoxon rank-sum test, while comparisons of categorical variables were carried out using Fisher’s exact test. Continuous measures are described by medians and ranges, and nominal variables are described with frequencies and percentages. Two multivariable linear regression models were then constructed to determine the association of variables of interest with infant mtDNA content and umbilical COX II:IV ratio, respectively. Both the HIV-infected and control groups were considered together in each model. Variables for each model were selected based on clinical significance, or selected based on significant Spearman correlation coefficient results. The level of significance for all analyses was set at 0.05. All Dasatinib analyses were performed using sas, version 9.1 (SAS Institute, Cary, NC, USA). HIV-infected women and healthy

uninfected control groups were not statistically different with regard to age, race and delivery variables, including time of ruptured membranes before delivery, and number of subjects who delivered their infants by Caesarean section (Table 1). HIV-infected women, however, had a higher pre-pregnancy body mass index (BMI) compared with the controls. Of note, none of the women had pre-eclampsia. Also, none of the women reported tobacco or alcohol use. One HIV-infected woman reported cocaine use. Maternal HIV those factors are also shown in Table 1. Fifty-five percent of women were ART-naïve prior to pregnancy. All women were on ART during pregnancy, with all but two on a protease inhibitor (PI)-based regimen with a dual NRTI backbone. The other two women were on a triple NRTI regimen. By the time of delivery, the majority of women had HIV-1 RNA levels <400 HIV-1 RNA copies/mL. Notably, all women who were on zidovudine (ZDV) during pregnancy were also on lamivudine (3TC) at the same time; however, there were some subjects who were on 3TC or emtricitabine (FTC) while not on ZDV. Fourteen HIV-infected women were on ZDV/3TC at some point during their pregnancies.