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Optimizing Malaria Treatment for HIV-Malaria Co-infected Individuals

NCT04708496 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 888

Last updated 2023-01-06

No results posted yet for this study

Summary

Optimal is a Randomized clinical trial to optimize treatment of malaria in HIV -malaria co infected patients. It has been demonstrated that, when the antimalarial drug Artemether Lumefantrine is co administered with Efavirenz based ART in HIV-malaria co-infected individuals, sub therapeutic levels of the drug are achieved hence resulting in poor malaria treatment outcomes.

The study then hypothesizes that, : HIV-malaria co-infected individuals receiving efavirenz-based ART plus a double-dose or 5-day course of artemether-lumefantrine will achieve higher and adequate artemether-lumefantrine serum concentrations with adequate 42-day treatment outcomes compared to individuals with HIV-malaria co-infection receiving efavirenz-based ART plus a standard-dose of artemether-lumefantrine.

Conditions

Interventions

DRUG

Artemether-lumefantrine

A three-arm single blind Randomized Clinical Trial in which HIV-malaria co-infected individuals with uncomplicated malaria receiving efavirenz-based ART will be randomized to one of three arms; a standard dose of artemether-lumefantrine, or a double dose of artemether-lumefantrine, or a 5-day course of artemether-lumefantrine for treatment of uncomplicated malaria. Participants will be followed up for 42 days to determine safety, drug pharmacokinetics and malaria treatment outcomes. The 4th objective focuses on the interaction between Dolutegravir and Artemether Lumefantrine hence this will be a single blind pharmacokinetic trial among HIV-malaria co-infected individuals receiving Dolutegravir based ART and standard dose of artemether-lumefantrine for treatment of uncomplicated malaria.

Sponsors & Collaborators

  • Makerere University

    lead OTHER

Principal Investigators

  • Pauline Byakika-Kibwika, PHD · IDI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2024-01-31
Completion
2024-03-31

Countries

  • Uganda

Study Locations

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Entities

Diseases

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 NCT04708496 on ClinicalTrials.gov