Optimizing malarial treatment in HIV and kidney disease patients ( Optimahk trial)

Open-Label, Randomized Controlled Study Comparing The Efficacy And Tolerability Of Artemether-Lumefantrine And Artesunate-Amodiaquine In Hiv Patients With Kidney Disease Treated With Dolutegravir-Based Antiretroviral Therapy

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202308810518432

Enrollment

120

Registered

2023-08-23

Start date

2022-08-15

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Malaria Kidney Disease

Interventions

Artemether lumefantrine group in HIV with kidney disease

Artemether lumefantrine group in HIV without kidney disease

Artesunate amodiaquine group in HIV with kidney disease

Artesunate amodiaquine group in HIV without kidney disease

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 years and older. 2. HIV positive 3. Fever (axillary temperature = 37.5°C), or history of fever in previous 48 hours; 4. Microscopic confirmation of asexual stages of P. falciparum or mixed infection or malaria parasite densities >2,000/?l 5. Receiving ART for at least 3 months. 6. Having CKD as evident by GFR <60 mL/min/1.73m2 and/or proteinuria 7. Willingness to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnancy. 2. Severe/complicated malaria. 3.Severe anaemia (<8.5 g/dl haemoglobin (Hb)); 4. Full course of AA or AL treatment or more than two doses of another antimalarial in the past four weeks. 5. Known hypersensitivity to artemisinin derivates, amodiaquine, artemether-lumefantrine, or raltegravir. 6. Patient on haemodialysis 7. Patient with a history of cardiac arrhythmias 8. Not willing to give informed consent

Design outcomes

Primary

Measure	Time frame
Efficacy outcome Parasite clearance time. Safety outcome Proportion of Adverse events (AEs)	—

Secondary

Measure	Time frame
Efficacy outcome 1. Fever clearance time. 2. Cure rate; 28-day Adequate clinical and parasitological response (ACPR) 3. Failure rate: •Early treatment failure (ETF), •Late clinical failure (LCF) •Late parasitological failure (LPF) Safety outcome 1. Serious adverse event (SAEs) - grades 3 and 4 2. Corrected QT (QTcF) interval prolongation 3. Change in hemoglobin concentration from baseline 4. Change in GFR from baseline 5. Change in liver transaminases from baseline.	—

Measure

Time frame

Efficacy outcome 1. Fever clearance time. 2. Cure rate; 28-day Adequate clinical and parasitological response (ACPR) 3. Failure rate: •Early treatment failure (ETF), •Late clinical failure (LCF) •Late parasitological failure (LPF) Safety outcome 1. Serious adverse event (SAEs) - grades 3 and 4 2. Corrected QT (QTcF) interval prolongation 3. Change in hemoglobin concentration from baseline 4. Change in GFR from baseline 5. Change in liver transaminases from baseline.

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Countries

Nigeria

Contacts

Public ContactSodiq Adeniyi

University of Lagos

adeniyisodiq65@gmail.com+2348102032598

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026