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| ID | Type | Description | Link |
|---|---|---|---|
| Allina IRB No. 2366-1 | |||
| Prism Research No. 714 | |||
| FDA IND No. 78958 |
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This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects of the pharmacokinetic interaction between raltegravir and Kaletra.
This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects. The initial cohort, to be studied simultaneously, will be 15 subjects with intention to collect complete data from 12 subjects. Replacements will be subsequently enrolled if necessary. Subjects will be reimbursed.
The periods will be
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | all subjects dosed the same |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir, lopinavir, ritonavir | Drug | 4 days of raltegravir, then 10 days of Kaletra, then 4 days of both with 12 PK sampling at the end of each period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| drug levels of lopinavir, ritonavir, raltegravir | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| safety | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank S Rhame, MD | Allina Hospitals & Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prism Research Inc | Saint Paul | Minnesota | 55114 | United States |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D011744 |
| Pyrimidinones |
| D011743 | Pyrimidines |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |