Optimizing Malaria Treatment for HIV-Malaria Co-infected Individuals (OPTIMAL)
HIV Coinfection, Malaria
About this trial
This is an interventional treatment trial for HIV Coinfection
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Infectious Diseases Institute
- Tororo District HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Standard dose of Artemether lumefantrine
Double dose Artemether lumefantrine
5 day course of Artemether lumefantrine
Dose comparison-concurrent control In this arm, Participants receiving Efavirenz400mg based ART will be randomized to standard dose Artemether Lumefantrine when treating uncomplicated malaria in HIV-malaria co-infected participants
Dose comparison concurrent control In this arm, Participants receiving Efavirenz based ART will be randomized to double dose Artemether Lumefantrine when treating uncomplicated malaria in HIV-malaria co-infected participants
Dose comparison concurrent control In this arm, Participants receiving Efavirenz based ART will be randomized to 5 day course of Artemether Lumefantrine as opposed to the standard 3day course when treating uncomplicated malaria in HIV-malaria co-infected participants