drugset / Trial / NCT00766818
The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lopinavir | Other / unclassified | 500 mg | — |
| Subject | Ritonavir | Other / unclassified | 125 mg | — |