Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine
NCT ID: NCT04531072
Last Updated: 2020-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2018-09-18
2019-08-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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ATVr-arm
10 participants living with HIV and having uncomplicated Falciparum malaria were administered: Atazanavir-ritonavir (300/100 mg) one tablet once daily continuously + tenofovir-lamivudine (300/300 mg) one tablet once daily continuously and artemether-lumefantrine (80/480 mg) one tablet twice daily for three days at 0, 8, 24, 36, 48 and 60 hour.
Artemether-lumefantrine
Safety and efficacy evaluation during concurrent use of artemether-lumefantrine and atazanavir-ritonavir based antiretroviral therapy
Atazanavir-ritonavir 300/100 mg
Safety and efficacy evaluation during concurrent use of artemether-lumefantrine and atazanavir-ritonavir based antiretroviral therapy
AL-arm (Control)
10 participants who were HIV negative but having uncomplicated Falciparum malaria were administered: Artemether-lumefantrine 80/480 mg, one tablet twice daily for three days at 0, 8, 24, 36, 48 and 60 hour.
Artemether-lumefantrine
Safety and efficacy evaluation during concurrent use of artemether-lumefantrine and atazanavir-ritonavir based antiretroviral therapy
Interventions
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Artemether-lumefantrine
Safety and efficacy evaluation during concurrent use of artemether-lumefantrine and atazanavir-ritonavir based antiretroviral therapy
Atazanavir-ritonavir 300/100 mg
Safety and efficacy evaluation during concurrent use of artemether-lumefantrine and atazanavir-ritonavir based antiretroviral therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed written consent,
* Malaria parasitaemia
* Axillary temperature ≥37.5°C or history of fever within 24 hours before visiting the clinic and with, at least, any of the following signs and symptoms of uncomplicated malaria: chills, sweats, headaches, muscle aches, nausea, vomiting, diarrhoea, body weakness, poor appetite and pallor.
* Hemoglobin (Hb) ≥8 g/dl
* Body weight ≥35 kg
* HIV positive (ATVr arm), HIV negative (AL/control arm)
Exclusion Criteria
* Smokers/alcoholics and users of substances which inhibit or induce CYP3A4 iso enzymes
* Withdrawal of consent
* Known allergy to any of the study drugs
* Development of complications or severe adverse effects
* Smokers/alcoholics and users of caffeine, drugs which induce or inhibit CYP3A4 and CYP2B6
* Evidence of chronic illnesses such as diabetes, hypertension, psychiatric illnesses
* Subject taking any drugs or having any condition known to prolong QT-intervals
* Signs of severe malaria
* Use of anti-tubercular drugs for at least three months prior to enrolment
* Being on anti-malarial drugs within four weeks prior to enrolment
* Pregnant or nursing mother.
18 Years
70 Years
ALL
Yes
Sponsors
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NIH Office of AIDS Research (OAR)
NIH
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Fogarty International Center of the National Institute of Health
NIH
Responsible Party
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Sikiru Olatunji Usman
Principal Investigator
Principal Investigators
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Sikiru Usman, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Lagos
Ibrahim Oreagba, Ph.D.
Role: STUDY_DIRECTOR
University of Lagos
Locations
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Apin (Aids Prevention Initiatives in Nigeria) clinic, Lagos University Teaching Hospital
Surulere, Lagos, Nigeria
Countries
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References
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Usman SO, Oreagba IA, Kadri MR, Adewumi OO, Akinyede A, Agbaje EO, Abideen G, Busari AA, Hassan OO, Akinleye MO, Akanmu AS. Evaluation of the effects of atazanavir-ritonavir on the pharmacokinetics of lumefantrine in patients living with HIV in Lagos University Teaching Hospital, South-Western Nigeria. Eur J Clin Pharmacol. 2021 Sep;77(9):1341-1348. doi: 10.1007/s00228-021-03116-x. Epub 2021 Mar 23.
Other Identifiers
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