The purpose of this study is to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.
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Number of women who meet area under the curve (AUC) target in second trimester (2T)
Timeframe: Measured at 2T (20 0/7 weeks to 26 6/7 weeks of pregnancy)
Number of women who meet area under the curve (AUC) target in third trimester (3T)
Timeframe: Measured at 3T (30 0/7 weeks to 37 6/7 weeks of pregnancy)
Number of women who meet area under the curve (AUC) in postpartum (PP)
Timeframe: Measured at PP (6 to 12 weeks after delivery)
Area under the curve (AUC) in second trimester (2T)
Timeframe: Measured at 2T (20 0/7 weeks to 26 6/7 weeks of pregnancy)
Area under the curve (AUC) in third trimester (3T)
Timeframe: Measured at 3T (30 0/7 weeks to 37 6/7 weeks of pregnancy)
Area under the curve (AUC) postpartum (PP)
Timeframe: Measured at PP (6 to 12 weeks after delivery)
Tenofovir-diphosphate (TFV-DP) concentrations in peripheral blood mononuclear cells (PBMCs) and dried blood spots (DBS) in second trimester (2T)
Timeframe: Measured at 2T (20 0/7 weeks to 26 6/7 weeks of pregnancy)
Tenofovir-diphosphate (TFV-DP) concentrations in peripheral blood mononuclear cells (PBMCs) and dried blood spots (DBS) in third trimester (3T)
Timeframe: Measured at 3T (30 0/7 weeks to 37 6/7 weeks of pregnancy)
Tenofovir-diphosphate (TFV-DP) concentrations in peripheral blood mononuclear cells (PBMCs) and dried blood spots (DBS) postpartum (PP)
Timeframe: Measured at PP (6 to 12 weeks after delivery)
Cord blood/maternal plasma concentration ratio at delivery
Timeframe: Measured on Day 0
Infant washout half-life after delivery (if not breastfeeding)
Timeframe: Measured on Day 0
Maternal breast milk/maternal plasma concentration ratio (if breast feeding)
Timeframe: Measured at Day 0
Infant plasma concentration at breast milk PK visit (if breast feeding)
Timeframe: Measured through Week 5
Area under the curve (AUC) at second trimester (2T)
Timeframe: Measured at 2T (20 0/7 weeks to 26 6/7 weeks of pregnancy)
Area under the curve (AUC) at third trimester (3T)
Timeframe: Measured at 3T (30 0/7 weeks to 37 6/7 weeks of pregnancy)
Area under the curve (AUC) postpartum (PP)
Timeframe: Measured at PP (6 to 12 weeks after delivery)
Area under the curve (AUC) at second trimester (2T)
Timeframe: Measured at 2T (20 0/7 weeks to 26 6/7 weeks of pregnancy)
Area under the curve (AUC) at third trimester (3T)
Timeframe: Measured at 3T (30 0/7 weeks to 37 6/7 weeks of pregnancy)
Area under the curve (AUC) postpartum (PP)
Timeframe: Measured at PP (6 to 12 weeks after delivery)
Maternal breast milk/maternal plasma concentration ratio
Timeframe: Measured through Week 24
Infant plasma concentration
Timeframe: Measured through Week 24