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Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine

NCT04531072 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-08-28

No results posted yet for this study

Summary

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

Conditions

  • Drug Interaction

Interventions

DRUG

Artemether-lumefantrine

Safety and efficacy evaluation during concurrent use of artemether-lumefantrine and atazanavir-ritonavir based antiretroviral therapy

DRUG

Atazanavir-ritonavir 300/100 mg

Safety and efficacy evaluation during concurrent use of artemether-lumefantrine and atazanavir-ritonavir based antiretroviral therapy

Sponsors & Collaborators

  • NIH Office of AIDS Research (OAR)

    collaborator NIH

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Fogarty International Center of the National Institute of Health

    lead NIH

Principal Investigators

  • Sikiru Usman, Ph.D. · University of Lagos

  • Ibrahim Oreagba, Ph.D. · University of Lagos

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2019-05-15
Completion
2019-08-15

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04531072 on ClinicalTrials.gov