drugset / Trial / NCT00766818

The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet

NCT00766818

Phase 1 Completed 12 enrolled University of North Carolina, Chapel Hill
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2007-01
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Lopinavir Other / unclassified 500 mg
Subject Ritonavir Other / unclassified 125 mg