Acquired Immunodeficiency Syndrome Clinical Trial
Official title:
Pharmacokinetics of Plasma Lopinavir/Ritonavir Over a 12 Hour Dosing Interval Following Administration of 400/100, 200/150, and 200/50 mg Twice Daily to HIV-negative Healthy Volunteers
The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir
over a 12-hour dosing interval, 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
Data during the development of lopinavir/ritonavir showed that lower drug doses had similar
efficacy to the standard dose of 400/100mg twice daily. Lower drug doses are also associated
with limited toxicity and cost.
The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir
following administration to male and female HIV−negative volunteers of 400/100mg, 200/150mg
and 200/50mg lopinavir/ritonavir twice daily. Each dosing phase will last for 7 days and
each phase will be separated by a 7-day wash-out period. Pharmacokinetic evaluations will be
made over a 12-hour interval at the end of each dosing phase.
Healthy subjects as determined by their medical history and physical examinations will be
eligible to participate in the study. HIV−positive subjects will not be recruited as there
is a risk that HIV−resistant mutations will be selected by an experimentally reduced dose of
lopinavir/ritonavir. 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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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