Trial no.:
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PACTR202308810518432 |
Date of Approval:
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23/08/2023 |
Trial Status:
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Retrospective registration - This trial was registered after enrolment of the first participant |
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TRIAL DESCRIPTION |
Public title
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Optimizing malarial treatment in HIV and kidney disease patients ( Optimahk trial) |
Official scientific title |
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 |
Brief summary describing the background
and objectives of the trial
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The burden of malaria/HIV coinfection is of great concern. The first-line drug management of malaria such as Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AA) in HIV-infected patients is still faced with the challenges of resistance treatment failure, organ toxicity, and serious pharmacokinetic alterations when administered to HIV patients. Most HIV patients infected with malaria are likely to be treated with AL and AA given that they are first-line ACTs. Because HIV patients on ART are also very prone to chronic kidney disease. Consequently, the drug-disease interaction may contribute to reduced renal clearance of the antimalaria and eventually affect the efficacy and safety of AL and AA when administered. Despite this significance, studies documenting the effect of kidney dysfunction on the outcome of AL and AA in HIV patients are limited. Additionally, bearing in mind the rapid uptake of dolutegravir (DTG) -containing ART as the first-line treatment of HIV in Nigeria, there exists the potential drug-drug interaction (DDI) between ACT and DTG-based ART. Hence, this necessitates the evaluation of antimalarial drug utilization and comparative outcome studies of artemether-lumefantrine and artesunate-amodiaquine among HIV patients with kidney disease. This study aims to assess and compare the effects of kidney dysfunction on the effectiveness and adverse event profile of the 2 most commonly used artemisinin-based combination therapy (ACT) in HIV patients with malaria to optimize the therapy. The objectives include:1.To determine the efficacy and assess the safety of Artemether-Lumefantrine (AL) among malaria/HIV-coinfected patients with kidney disease. 2. To determine the efficacy and assess the safety of Artesunate-Amodiaquine (AA) among malaria/HIV-coinfected patients with kidney disease. 3. To compare the treatment outcome of Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AA) among malaria/HIV-coinfected patients with kidney disease. |
Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
Optimahk |
Disease(s) or condition(s) being studied |
Infections and Infestations,Kidney Disease |
Sub-Disease(s) or condition(s) being studied |
HIV/AIDS,Malaria |
Purpose of the trial |
Treatment: Drugs |
Anticipated trial start date |
15/08/2022 |
Actual trial start date |
04/10/2022 |
Anticipated date of last follow up |
06/09/2024 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
120 |
Actual target sample size (number of participants) |
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Recruitment status |
Recruiting |
Publication URL |
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