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The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet: A Longitudinal Investigation in the Second and Third Trimesters Including Empiric Dosage Adjustment
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).
Details
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 12 |
| Start date | 2007-01 |
| Completion | 2010-03 |
Conditions
- Pregnancy
- HIV
Interventions
- Kaletra
Primary outcomes
- 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. — 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. — 20-24weeks, 30 weeks, 32 weeks gestation, 8weeks postpartum
Countries
United States