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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01159275
Study type Interventional
Source The HIV Netherlands Australia Thailand Research Collaboration
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 2009
Completion date March 2010

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