HIV Infections Clinical Trial
Official title:
Cross-sectional Study for the Characterisation of the Pharmacokinetic Parameters of Protease Inhibitors and Non-nucleoside Analog Reverse Transcriptase Inhibitors in the Spanish Population of HIV-infected Subjects
The purpose of this study is to characterise the pharmacokinetic profiles of non-nucleoside analog reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs), and the influence of the individual characteristics on the pharmacokinetic parameters in the Spanish population of HIV-infected subjects.
The antiretrovirals were administered conventionally according to fixed dosage systems, or
depending on the weight of the individual in the case of certain agents. However, the plasma
levels of antiretrovirals following the administration of a fixed dose present a marked
interindividual variability. Moreover, a significant proportion of the patients on treatment
with PIs presented plasma levels regarded as suboptimal in previous studies.
Moreover, for the correct modification of the dosage of a drug, populational data on its
pharmacokinetic behaviour during the dosing interval is required. Only by integrating this
information with the specific characteristics of each individual is it possible, using
mathematical models, to estimate the effect that a modification of the dosage of the drug
would have on its plasma concentration. However, populational data on the pharmacokinetic
behaviour of antiretroviral agents are still very limited at this moment, and have not always
been obtained in populations similar to the one to which they are to be applied.
Thus, knowing the pharmacokinetic behaviour of the antiretroviral agents in our population
and the influence of certain individual characteristics on this behaviour may be of great
interest, since only in this way will we be able to tailor the dosage of antiretrovirals
reliably in our patients.
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