Effect of Imatinib on Suppression of Malaria Parasites in Patients With Uncomplicated Plasmodium Falciparum Malaria

NCT02614404 | Completed Phase 1 DMC

• 1 other identifier: HuLow-201605
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy and safety of imatinib in combination with dihydroartemisinin plus piperaquine in the treatment uncomplicated P. falciparum malaria in adult male patients.

Conditions

Plasmodium Falciparum Malaria

Keywords

Plasmodium falciparum; Uncomplicated malarial; imatinib mesylate; antimalarials

Outcome Measures

Primary Outcomes (2)

• Time to Parasite Clearance

  Parasite clearance was determined by assessing the parasite count in blood, using thin film, thick film and qPCR analysis

  From baseline to the time point when the blood parasite count is zero (up to a maximum of 5 days)

• 28-day Cure Rate

  28-day cure rate was defined as the percentage of participants with blood parasite count of zero after 28 days of treatment and no evidence of recurrent infection with the same parasite genotype after reduction of the asexual parasitemia. Follow up after treatment will only be performed in the case of complete clearance of parasites at D5 due to Imatinib treatment.

  Day 28

Secondary Outcomes (1)

• Frequency of adverse events

  Within 1 week of beginning treatment with imatinib

Study Arms (2)

Imatinib combination therapy

EXPERIMENTAL

Administration of imatinib (400 mg/day) plus dihydroartemisinin (40 mg/day) plus piperaquine (320 mg/day) to uncomplicated adult male malaria patients. Normal health parameters will be monitored continuously to evaluate safety and the decrease in peripheral blood parasitemia with time will be quantitated to assess efficacy.

Drug: Imatinib combination therapy

dihydroartemisinin plus piperaquine

ACTIVE COMPARATOR

Administration of dihydroartemisinin (40 mg/day) plus piperaquine (320 mg/day) to uncomplicated adult male malaria patients. Normal health parameters will be monitored continuously to evaluate safety and the decrease in peripheral blood parasitemia with time will be quantitated to assess efficacy.

Drug: Dihydroartemisinin-piperaquine

Interventions

Imatinib combination therapy DRUG

Imatinib plus dihydroartemisinin plus piperaquine

Also known as: Gleevec, Glivec

Imatinib combination therapy

Dihydroartemisinin-piperaquine DRUG

Standard of care

Also known as: Artekin, Eurartesim, Diphos, Timequin, Duocotecxin, Malacur, Ridmal

dihydroartemisinin plus piperaquine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gender: only adults are selected for the trial; note that female subjects cannot be women of child-bearing age.
• Age: 18-50 years.
• Target disease: Uncomplicated Plasmodium falciparum malaria

You may not qualify if:

• symptoms and signs of complicated malaria
• including continuous high fever of over 390C, psychiatric disorders, confusion, other neurological symptoms, symptoms and signs of functional impairment of the organs such as lungs, kidneys or cardiovascular system;
• symptoms and signs of liver damage or kidney damage
• symptoms and signs of another complicating infection such as pneumonia, dengue fever, and other bacterial infection.
• P. falciparum \> 25.000 / mm3
• WBC \<4000 and \>10.000 /mm3
• RBC \< 3.5x106/mm3
• Platelets \< 40.000 /mm3
• Hemoglobin \< 10 g/dL
• ALT more than 200% of the upper limit (56 units/L)
• AST more than 200% of the upper limit (40 units/L)
• Blood creatine more than 75% of the upper limit (men: 1.2 mg/dL, women 1 mgdL)
• Serum total protein \< 6 g/L
• Glycemia \< 50 mg/dL\> 200 mg/dL
• Standard urine test Serious alterations

Sponsors & Collaborators

• HuLow: lead
• Purdue University: collaborator
• University of Turin, Italy: collaborator
• Università degli Studi di Sassari: collaborator
• Hue University: collaborator

Study Sites (1)

A Tuc

Hương Hóa, Quang Tri, 520000, Vietnam

Location

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Imatinib Mesylate; benzene-1,4-diphosphonic acid

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Huynh D Chien, MD, PhD

  Hue University

  PRINCIPAL INVESTIGATOR

• Francesco M Turrini, MD, PhD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

• Philip S Low, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 25, 2015
• Study Start: November 1, 2015
• Primary Completion: December 2, 2016
• Study Completion: February 2, 2017
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

VN (1)