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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Kaletra |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kaletra | Drug | Kaletra 400/100mg BID, then increase at 30weeks to 500/125mg BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20-24weeks, 30weeks, 32weeks gestation, 8 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela DM Kashuba, PharmD | University of North Carolina | Principal Investigator |
| Kristine B Patterson, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| C558899 | lopinavir-ritonavir drug combination |
| D061466 | Lopinavir |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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