In this study, we are looking at blood concentrations of Kaletra in HIV positive patients during pregnancy. The patients will come in for 4 visits lasting \~24hrs. These visits take place at 20-24 weeks, 30 weeks, 32 weeks and 8 weeks post-partum. At the end of vist 2 (week 30), we will increase your dose to 2 adult Kaletra tablets, and one pediatric Kaletra tablet (total dose 500/125mg). The dose will remain increased until you are 2 weeks post partum, then it will return to the standard 2 adult tablets (400/100mg).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Kaletra 400/100mg BID, then increase at 30weeks to 500/125mg BID
University of North Carolina
Chapel Hill, North Carolina, United States
To compare the C12h and AUC0-12h of protein bound and unbound blood plasma lopinavir (LPV) using standard doses during the second and third trimesters of pregnancy.
Time frame: 20-24 weeks, 30weeks, 32 weeks gestation and 8 weeks postpartum
To compare the C12h and AUC0-12h of protein bound and unbound blood plasma LPV between standard doses (400mg/100mg BID) and increased doses (500/125mg BID) of Kaletra® during the third trimester of pregnancy.
Time frame: 20-24weeks, 30 weeks, 32 weeks gestation, 8weeks postpartum
To compare the C12h and AUC0-12h of protein bound and unbound blood plasma ritonavir (RTV) using standard doses during the second and third trimesters of pregnancy.
Time frame: 20-24weeks, 30weeks, 32weeks gestation, 8 weeks postpartum
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.