ABSTRACT
OBJECTIVES: Our objective was to evaluate the pharmacokinetics of nelfinavir (NFV) (625 mg tablets) 1250 mg twice daily during pregnancy and postpartum. METHODS: The participants were HIV-1-infected pregnant women enrolled in P1026s and receiving NFV (625 mg tablets) 1250 mg twice daily as part of routine clinical care. Intensive steady-state 12-h NFV pharmacokinetic profiles were performed during pregnancy and postpartum. The target NFV area under the plasma concentration-time curve (AUC(0-12)) was >or=10th percentile NFV AUC(0-12) in non-pregnant historical controls (18.5 microg h/mL). RESULTS: Of 27 patients receiving NFV, pharmacokinetic data were available for four (second trimester), 27 (third trimester) and 22 (postpartum) patients. The NFV maximum concentration (C(max)), 12-h post-dose concentration (C(12)) and AUC(0-12) were significantly lower during the third trimester compared to postpartum (PSubject(s)
HIV Infections/drug therapy
, HIV Protease Inhibitors/pharmacokinetics
, HIV-1
, Nelfinavir/pharmacokinetics
, Pregnancy Complications, Infectious/drug therapy
, Adolescent
, Adult
, Area Under Curve
, CD4 Lymphocyte Count
, Drug Administration Schedule
, Female
, HIV Infections/metabolism
, HIV Protease Inhibitors/administration & dosage
, Humans
, Infant, Newborn
, Nelfinavir/administration & dosage
, Pregnancy
, Pregnancy Complications, Infectious/metabolism
, Puerperal Infection/drug therapy
, Puerperal Infection/metabolism
, RNA, Viral
, Viral Load
, Young Adult