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Pharmacokinetics of Lopinavir/Ritonavir at Three Different Doses.

2014-08-27 03:19:00 | BioPortfolio

Summary

The successful treatment of HIV infection relies on the use of combinations of antiretroviral therapy (cART) to achieve durable viral suppression and to minimize the emergence of resistant viral strains. Recommended doses for antiretroviral (ARV) drugs are often determined early in clinical development by an innovator company fast−tracking the drug to market. Clinical and pharmacokinetic (PK) (mechanisms of absorption and distribution) evidence indicates that the recommended doses of certain ARVs should be reappraised. This may particularly be true for a class of ARV's boosted protease inhibitors, such as Kaletra (lopinavir/ritonavir).nThe purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir over 12 hours dosing interval of following administration to male and female HIV−negative healthy volunteers of:

1. Lopinavir/ritonavir 400/100 mg twice daily

2. Lopinavir/ritonavir 200/150 mg twice daily

3. Lopinavir/ritonavir 200/50 mg twice daily

Description

The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir over the 12 hour dosing interval following administration to male and female HIV−negative volunteers of either 400/100mg, 200/150mg, 200/50mg lopinavir/ritonavir twice daily. data during the development of lopinavir/ritonavir shows that lower drug concentration have shown similar efficacy and limited toxicity and cost. Healthy subjects as determined by their medical history and physical examinations will be eligible to participate in the study. The purpose or recruiting healthy and not HIV−positive subjects is that HIV−positive subjects would risk the selection of HIV−resistant mutations, particularly when the volunteers are receiving experimental dose reduced regimen of lopinavir/ritonavir. In addition, there is no reason to presume that there is any meaningful difference in the metabolic processing of lopinavir/ritonavir between HIV−infected and HIV−uninfected people.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Healthy

Intervention

Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets BID), Lopinavir/ritonavir 200/150 mg twice daily, Lopinavir/ritonavir 200/50 mg twice daily

Status

Enrolling by invitation

Source

The National Centre in HIV Epidemiology and Clinical Research

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:00-0400

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