Safety and Tolerability of Chlorquine in Addition to Anti-tuberculosis Therapy

Launched by UNIVERSITY OF ZURICH · Jun 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and tolerability of a medication called Chloroquine when used alongside standard treatment for tuberculosis (TB). Previous research has shown that Chloroquine may help boost the effectiveness of TB treatments, but researchers want to ensure that using both together is safe. The study is currently looking for healthy volunteers aged between 18 and 50 years to participate.

If you qualify and choose to join the trial, you will receive both Chloroquine and standard TB medication. Throughout the study, your health will be closely monitored to check for any side effects or issues that may arise from the combination of these treatments. It's important to know that women participating in the trial will need to use effective contraception during the study and for a period afterward. This trial is a crucial step in understanding how to improve TB treatment safely, and your participation could help advance medical knowledge in this area.

Gender

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Eligibility criteria

• Inclusion criteria:
• • 1. Informed study-specific consent (including possible pharmacogenetic analysis) as documented by signature
• • 2. Healthy volunteers aged between 18 and 50 years of age (significantly increased risk of side effects from 50 years of age with Rimstar®)
• Exclusion criteria:
• 1. Lack of highly effective contraception during the study treatment and for 8 months after the last dose of study treatment (until Day 254, visit 7) according to 11.4 with the following consideration for participating women:
• • From Day 1 (visit 2) up to Day 30 (visit 6) hormonal contraception is insufficient due to lower concentrations of estrogen and/or gestagen during and up to 14 days after Rimstar® intake. The hormonal contraception must be supplemented with a barrier method (preferably male condom).
• • From Day 30 (visit 6) up to Day 254 (visit 7) hormonal contraceptive methods can be used and are considered highly effective.
• • 2. Pregnant or lactating females
• • 3. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, glucose-6-phosphate dehydrogenase insufficiency (favism)
• • 4. Regular treatment with drugs in the last 14 days prior to first intake of study drug (except for Paracetamol and Vitamin B6 (pyridoxine), see 8.7).
• • 5. History of or concurrent, clinically significant cardiac, immunological, pulmonary, neurological, renal, gastrointestinal, dermatological, endocrinological or other major disease as determined by the Investigator and/or his representative
• • 6. History of or presence of any clinically significant abnormality in vital signs, ECG, or laboratory test results or has any medical or psychiatric condition that, in the opinion of the Investigator, may interfere with the study procedures or compromise subject safety
• • 7. History of or currently present retinopathy or other disturbances of the field of vision or the retina according to the Investigator
• • 8. History of alcohol or substance abuse for the last 3 months prior to Screening, as determined by the Investigator
• • 9. Weight less than 55kg
• • 10. Intake of grapefruit juice or grapefruits within 2 weeks before the first study drug administration and during treatment phase
• • 11. Donation of blood or blood products within a 30-day period prior to Screening
• • 12. Current enrolment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 3 months of participation to the Clear trial.
• • 13. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• • 14. The investigator, his/her family members, employees and other dependent persons