HIV Infections Clinical Trial
Official title:
Clinical Pilot Trial to Evaluate the Influence of Nevirapine in Exposure to Atazanavir in Steady State Equilibrium in HIV-infected Adult Patients.
The purpose of this study is to evaluate the influence of nevirapine in exposure to atazanavir boosted with ritonavir, in steady state equilibrium, in HIV-infected adult patients.
In recent years, new treatment strategies have appeared aimed at reducing the risk of
treatment-derived toxicity without compromising efficacy.
Of the recent antiretroviral drugs, atazanavir is a protease inhibitor (PI) whose
pharmacokinetic profile allows it to be given in a single daily take with a scant impact on
lipid metabolism. This second characteristic makes atazanavir a good alternative for patients
with a high vascular risk. However, one of its drawbacks is that it may present clinically
relevant interactions with other drugs.
Another antiretroviral agent with a scant impact on lipid metabolism is nevirapine. Different
studies have described an improvement in lipid profile, as well as a less atherogenic
tendency in patients treated with nevirapine. Moreover, the combination of nevirapine with PI
drugs in the context of nucleoside-sparing strategies may permit a suitable control of viral
replication, and an improvement in the mitochondrial toxicity derived from treatment with
NTRI, which may possibly result in a minor incidence or in a clinical improvement of
lipodystrophy.
The combination of atazanavir with nevirapine may be of major interest in HIV-infected
patients that have had a cardiovascular event (secondary prevention) or are at a high risk of
having one (primary prevention). Similarly, this combination of drugs may be promising as a
nucleoside-sparing strategy. However, according to preliminary data, the joint administration
of nevirapine with atazanavir may lead to a reduction in the atazanavir plasma concentration.
Thus, before evaluating the clinical utility of this combination of drugs, pharmacokinetic
studies evaluating the existence of significant pharmacokinetic interactions between both are
necessary
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