Status:
UNKNOWN
Optimizing Malaria Treatment for HIV-Malaria Co-infected Individuals
Lead Sponsor:
Makerere University
Conditions:
HIV Coinfection
Malaria
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ad...
Detailed Description
Malaria and HIV have significant interactions at various levels. The geographical and epidemiological overlap increases risk for co-infection and co-treatment. The immune suppression due to HIV increa...
Eligibility Criteria
Inclusion
- Written informed consent
- Willing and able to comply with study treatment and procedures
- Age above 18 years
- Confirmed HIV positive and receiving efavirenz or dolutegravir based ART for objectives 3 and 4
- Confirmed Malaria blood film positive without evidence for severe malaria for objectives 3 and 4
- Confirmed Malaria blood film negative for objectives 1 and 2
Exclusion
- Serum alanine transaminase levels above 3x upper limit of normal
- Serum creatinine levels above 2x upper limit of normal
- Use of known inducers/inhibitors of CYP or glucuronyl transferase UGT1A1 within past 2 months (e.g. anticonvulsants, TB medications, HIV agents for prophylaxis, azole antifungals)
- Pregnant women or female subjects who are unwilling to use a suitable contraceptive method for the duration of the study (condom, diaphragm, IUD or contraceptive implant)
- Likely to be poorly adherent based on clinician's medical judgement
- Known to be current injection drug user
- Administration of any additional antimalarial drugs that are not study drugs within 24 hours before study enrollment and during the course of the study.
- Presence of any non-malarial febrile illness which may interfere with the classification of malaria treatment outcome
- Movement away from the study area interfering with follow-up assessment
- Patients with contraindications to taking the study drugs
- Evidence of QT prolongation on ECG (rate adjusted QT interval\>45ms (men (or \>470ms for women
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
888 Patients enrolled
Trial Details
Trial ID
NCT04708496
Start Date
January 18 2021
End Date
March 1 2024
Last Update
January 6 2023
Active Locations (2)
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1
Infectious Diseases Institute
Kampala, Uganda
2
Tororo District Hospital
Tororo, Uganda, P.O Box 1