Safety and Tolerability of Chlorquine in Addition to Anti-tuberculosis Therapy
ConditionTuberculosis Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Zurich
About this trial
In vitro and in vivo data show promising results of adjunctive use of Chloroquine to standard tuberculosis therapy as Chloroquine enhances animicrobial effectiveness against intracellular MTB. To date, no safety data of the concurrent use of both treatments is availble. In a phase I trial, the investigators aim to evaluate safety and tolerability of the concurrent use of Chloroquine and standard anti-TB drug in healthy volunteers.
Eligibility criteria
Qualifiers
Informed study-specific consent (including possible pharmacogenetic analysis) as documented by signature
Healthy volunteers aged between 18 and 50 years of age (significantly increased risk of side effects from 50 years of age with Rimstar®)
Disqualifiers
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.
Pregnant or lactating females
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)
Trial design
Treatments tested in this trial
- Nivaquine ® (Chloroquine)
Treatment groups
16 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov