ACTRN12616000174482CompletedPhase 1
A Phase IB Experimental Study to Assess the in vivo Safety and Response to Chloroquine of Plasmodium vivax isolate HMPBS02-Pv in Healthy Participants with Induced Blood Stage Malaria Infection
QIMR Berghofer Medical Research Institute0 sites24 target enrollmentStarted: February 11, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- All
Inclusion Criteria
- •1. Adults (male and non-pregnant, non-lactating female) participants between 18 and 55 years of age, inclusive who do not live alone (from Day 0 until at least the end of the anti-malarial drug treatment) and will be contactable and available for the duration of the trial and follow up period (maximum of 6 weeks).
- •2. Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- •3. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- •4. Normal vital signs after 5 minutes resting in supine position
- •5. Normal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position
- •6. Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy participants enrolled in this clinical investigation.
- •7. As there is the risk of adverse effects of the study treatment drug (chloroquine), in pregnancy, it is important that any participants involved in this study do not get pregnant
- •8. All participants must be Duffy Blood group positive. Female participants of childbearing potential should be blood group Rh positive.
- •9. Female participants of childbearing potential and all male participants must also have adequate contraception in place for the duration of the study
Exclusion Criteria
- •1. Any history of malaria or participation to a previous malaria challenge study
- •2. Any history of retinal abnormalities, disease of the retina or macula of the eye, visual field defects, hearing disorders (e.g. reduced hearing, tinnitus).
- •3. Must not have travelled to or lived (>2 weeks) in a malaria-endemic region during the past 12 months or planned travel to a malaria-endemic region during the course of the study.
- •4. Has evidence of increased cardiovascular disease risk
- •5. History of splenectomy
- •6. Presence of acute infectious disease or fever (e.g., sub-lingual temperature greater than or equal to 38.5°C) within the 5 days prior to inoculation with malaria parasites.
- •7. Evidence of acute illness within the 4 weeks before trial prior to screening that the Investigator deems may compromise participant safety.
- •8. Participant has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion, e.g. gastrectomy, diarrhoea.
- •9. Participation in any investigational product study within the 12 weeks preceding the study.
- •10. Blood donation, any volume, within 1 month before inclusion or participation in any research study involving blood sampling (more than 450 mL/unit of blood), or blood donation to Red Cross (or other) blood bank during the 8 weeks preceding the reference drug dose in the study.
- •11. Participant who has ever received a blood transfusion
- •12. Any recent (less than 6 weeks) or current systemic therapy with an antibiotic or drug with potential anti-malarial activity (i.e. chloroquine, piperaquine, benzodiazepine, flunarizine, fluoxetine, tetracycline, azithromycin, clindamycin etc.)
- •13. Cardiac/QT risk
- •14. Known hypersensitivity to chloroquine, or any of its excipients or 4-aminoquinolines, artemether or other artemisinin derivatives, lumefantrine, or other arylaminoalcohols.
- •15. Known severe reaction to mosquito bites other than local itching and redness.
- •16. Unwillingness to abstain from consumption of citrus (grapefruit, Seville orange, etc.) for greater than or equal to 21 days prior to initiation of the study (inoculation, Day 0) and for the study duration
Investigators
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