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| Name | Class |
|---|---|
| Ministry of Education, Thailand | OTHER |
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The purpose of this study is to study the pharmacokinetics profiles of generic lopinavir/ritonavir and Pediatric Aluvia® at reduced dose by assessing safety, tolerability and efficacy.
This is a prospective, 2 arms, randomized intensive PK study with cross over design. This design will provide us optimal information to answer our research question. First and most important, we can assess the PK when lopinavir/r is used in a dose reduced form. By randomizing the patients to either Abbott's pediatric Aluvia dose reduction or India generic LPV/r dose reduction will allow us to assess the differences in AE severity and frequency. Using the standard abbott product as a control our study will provide important information about the bioavailability of the generic product. Although it's not an original BE design we must be able to make preliminary comparisons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | First Generic LPV/r 200/50 mg BID, then cross over to Pediatric Aluvia 200/50 mg BID |
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| 2 | Other | First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Generic LPV/r and Aluvia (pharmacokinetics) | Drug | Generic LPV/r 200/50 mg BID 12 hr PK then cross over to Pediatric Aluvia 200/50 mg BID |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC, Cmin, Cmax of LPV/r between Aluvia and generic | AUC, Cmin, Cmax of LPV/r between Aluvia and generic | week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anchalee Avihingsanon, MD | The HIV Netherlands Australia Thailand Research Collaboration | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIV-NAT, Thai Red Cross AIDS Research Centre | Bangkok | 10330 | Thailand |
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| Label | URL |
|---|---|
| HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) | View source |
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| ID | Term |
|---|---|
| C558899 | lopinavir-ritonavir drug combination |
| D010599 | Pharmacokinetics |
| ID | Term |
|---|---|
| D008660 | Metabolism |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
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| Aluvia and Generic LPV/r (pharmacokinetics) | Drug | First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID |
|