Drug Interaction Clinical Trial
Official title:
Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine in People Living With HIV Attending Lagos University Teaching Hospital
A case control pharmacokinetic study evaluating the effects of atazanavir-ritonavir on the pharmacokinetics and toxicity of lumefantrine in people living with HIV attending APIN clinic of the Lagos University Teaching Hospital
Atazanavir-ritonavir (ATVr) based antiretroviral therapy and artemether-lumefantrine (AL) are
commonly used drugs for the treatment of Human Immune Deficiency Virus (HIV) infection and
malaria respectively in Nigeria. However, both drugs interact with Cytochrome P 3A4 (CYP 3A4)
isoenzymes which may spawn clinically significant pharmacokinetic interactions.
The study was aimed at evaluating the effects of atazanavir-ritonavir on the pharmacokinetics
and toxicity of lumefantrine.
In a case control pharmacokinetic study, twenty participants who tested positive for
Plasmodium falciparum malaria were recruited and divided into two groups (ATVr-arm, n=10; and
Control-arm, n= 10). All the participants were administered with 6 doses of AL 80-480 mg
(Coartem). Thereafter, blood samples were collected from them at different time intervals
over seven days. The lumefantrine concentration in each sample was determined with
high-performance liquid chromatography (HPLC) and entered into WinNonlin® software to
determine the pharmacokinetic parameters of lumefantrine which were compared between the test
and control groups. Toxicity was evaluated with adverse events monitoring,
electrocardiography, haematological and blood chemistry tests at pre and post doses of
artemether-lumefantrine.
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