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Professor
Pauline Byakika-Kibwika

Uganda
Uganda
Uganda

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Project Title

Optimizing Malaria Treatment for HIV-Malaria co-infected Individuals by Addressing Drug Interactions between Artemisinin-based Combination Therapies and Antiretroviral Drugs (OPTIMAL)

Project Objectives

General Objective: To utilize innovative interventions to overcome drug interactions between artemether-lumefantrine and efavirenz to guide malaria treatment for individuals co-infected with HIV and malaria Specific Objectives 1. To determine the safety and Pharmacokinetics of the double dose artemether-lumefantrine when administered to healthy volunteers (malaria negative and HIV negative individuals). 2. To determine the safety and Pharmacokinetics of the 5-day course of artemether-lumefantrine when administered to healthy volunteers (malaria negative and HIV negative individuals). 3. To determine the safety, pharmacokinetics, and malaria treatment outcome of a standard dose of artemether-lumefantrine compared to double of the standard dose for weight and a 5-day course of artemether-lumefantrine for treatment of uncomplicated malaria among HIV-Malaria co-infected individuals receiving efavirenz (400mg) based ART. 4. To determine the safety, Pharmacokinetics, and malaria treatment outcome of artemether-lumefantrine when administered with Dolutegravir based ART among HIV-malaria co-infected individuals.

Results & Outcomes

6We screened thirty-nine and enrolled thirty-two participants. Seven participants were excluded because of the following reasons; breastfeeding, pregnancy, concomitant use of AL, very high blood pressure, abnormal ECG, Hepatitis B positivity, and elevated AST. Data analysis and manuscript writing are ongoing.The PI enrolled three (3) students for the Masters of Medicine in Internal Medicine Training Program (MMed Int Med) and one (1) student for training in PhD in Health Sciences Program at Makerere University College of Health Sciences. All the 4 students were required to attend coursework and to develop research protocols in the area of malaria or antimicrobial resistance. They have been mentored and their research projects reviewed and approved by the Research Ethics Committee and supervised by the PI. All students have successfully completed the required course units. One MMed student has completed research data collection, analysis and report write up and is writing the manuscript, and the two MMed students and the PhD candidate are collecting data. The PI has had continuous mentorship, supervision and engagement with the students which has facilitated students’ progress and will bring them to successful completion of the training program. Under this program we have held training seminars on Antimicrobial Resistance (AMR) expanding to include both antibiotics and antimalarial resistance which are currently a big threat especially in African countries, where the poorest communities face the highest burden of infectious diseases.

Host Organisation

Department Institution Country
Infectious Diseases Institute Limited (IDI) UG

EDCTP Project

TMA2017SF-1943

EDCTP Program

EDCTP2

EDCTP Project Call

Senior Fellowship (SF)

Study Design

Randomised Clinical and Pharmacokinetic Trial

Project Summary

To train and conduct a Randomised Clinical and Pharmacokinetic Trial to generate data to optimize malaria treatment for individuals co-infected with HIV and malaria, by utilizing innovative interventions to overcome the significant drug interactions between artemether-lumefantrine and efavirenz.

Project Title

Comparison of efficacy, safety and pharmacokinetics of intravenous artesunate and intravenous quinine followed by oral artemisinin combination therapy for severe malaria treatment in Uganda AND evaluation of pharmacokinetic drug interactions of artesunate, quinine, lumefantrine and piperaquine with antiretroviral drugs

Project Objectives

To evaluate the effectiveness of IV artesunate plus ACT and IV quinine plus ACT as well as to study the pharmacokinetics of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) for treatment of severe malaria in adults and children in Tororo district hospital, Uganda. 1. To compare treatment outcome (measured as risk of recurrent parasitaemia and risk of recurrent symptomatic malaria) following treatment with IV quinine followed by oral ACT (Artemether-Lumefantrine or Dihydroartemisinin-piperaquine) and IV artesunate followed by oral ACT (AL or DP) for treatment of severe malaria in Ugandan patients 2. To compare parasite clearance time following treatment with IV quinine followed by oral ACT (AL or DP) and IV artesunate followed by oral ACT (AL or DP) for treatment of severe malaria in Ugandan patients 3. To investigate the pharmacokinetic parameters of IV quinine, IV artesunate, oral AL and oral DP during severe malaria treatment in Ugandan patients and correlate these with treatment outcome 4. To investigate the pharmacokinetic drug interactions of quinine, artesunate, lumefantrine and piperaquine with the antiretroviral drugs (Nevirapine, Efavirenz, Lopinavir/ritonavir) in Ugandan patients.

Results & Outcomes

Follow-up of 274 study participants sucessfully completed. Samples for genotyping successfully analysed at the Mulago Molecular Biology laboratory. Samples for drug assays shipped to Mahidol Clinical Pharmacology Laboratory, Thailand.Preliminary results: 1. Rate of achieving failure among patients who received IV Artesunate is higher than in patients who received IV Quinine. 2. Rate of achieving recrudescence is higher among patients who received IV Quinine, compared to those that received IV Artesurate. 3. Probability of acquiring recrudescence is highest among the patients that received IV Quinine + DP.

Host Organisation

Department Institution Country
Infectious Diseases Institute Makerere University College Of Health Sciences UG
Medicine Makerere University UG

EDCTP Project

TA.2009.40200.020

EDCTP Program

EDCTP1

EDCTP Project Call

Senior Fellowship (SF)

Study Design

PK and drug interaction studies

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