A Phase 2/3 interventional study of Nifurtimox and Benznidazole in Chagas Disease, sponsored by Universidad Autónoma de Bucaramanga. Status unknown at 1 site in Colombia. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by Universidad Autónoma de Bucaramanga · Phase 2/3, Interventional, and Treatment
This randomized, blind, parallel-group trial will evaluate the efficacy and safety of Nifurtimox (NFX) and Benznidazole (BZN), the two usual interventions to treat the parasite Trypanosoma cruzi.
The investigators will test whether NFX is an effective trypanocidal agent (by comparison with placebo) and equivalent to BZN (as active comparator) in terms of both parasite-related and safety outcomes.
Individuals found seropositive and without clinical signs of dilated cardiomyopathy will receive either of the active treatments or matching placebo. Participants allocated to NFX or BZN will receive either a 60-day (full-dose) or a 120-day (half-dose) active treatment, whereas the control group will receive placebo for 120 days. There will be thus four arms of active treatment (NFX60, NFX120, BZN60 and BZN120), and a fifth control arm receiving placebo (1:1:1:1:1 allocation ratio) where every participant in the trial will take 120 days of study drug (the groups receiving full-dose will complete a 120-day masked treatment with placebo).
The study plans to enroll 500 participants from Colombia (in two different geographical areas) and Argentina, in order to explore regional differences in the treatment effects.
The specific aims of this multi-center randomized trial include:
To evaluate the feasibility of conducting a multinational trial in terms of
Exclusion Criteria:
60 days of active treatment with full-dose, or 120 days of active treatment with half-dose (allocation ratio 1:1). The 60-day group will receive active treatment in the first or second half of a 120-day treatment window, as per random allocation. The active treatment period will be followed/preceded by matching placebo (see placebo arm below)
Drug: Nifurtimox
60 days of active treatment with full-dose, or 120 days of active treatment with half-dose (allocation ratio 1:1). The 60-day group will receive active treatment in the first or second half of a 120-day treatment window, as per random allocation. The active treatment period will be followed/preceded by matching placebo (see placebo arm below)
Drug: Benznidazole
120 days of treatment with matching placebo
Drug: Placebo
Full dose: 8 mg/Kg/day, assuming an average weight of 60 Kg: 240 mg B.I.D Half-dose: 120 mg B.I.D
Also known as: Lampit (Bayer)
Full dose: 5 mg/Kg/day, assuming an average weight of 60 Kg: 150 mg B.I.D Half dose: 75 mg B.I.D
Also known as: Radanil (Roche), Rochagan (Roche), Abarax (ELEA)
Two capsules of matching placebo (contaning Magnesium stearate and cellulose) B.I.D
Also known as: Control group
Quantitative Polymerase Chain Reaction (qPCR) for Trypanosoma cruzi
Proportion of participants with at least one out of three positive tests (performed at least one week apart from each other)
Time frame: 12 - 18 months after starting therapy
T. cruzi positive serology status
Proportion of participants with positive T. cruyzi serology status
Time frame: 12 months after starting therapy
Mean change in T. cruzi antibody titers
Mean change (before-after) in antibody readings as measured with ELISA serology
Time frame: 12 months after starting therapy
Reported adverse reactions
Proportion of participants with at least one of the following a) Reporting hospitalization or inability to work b) Stopping study treatment because of adverse reactions /intolerance c) having abnormal levels of at least two biochemical or blood markers
Time frame: 60 days after starting therapy
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Universidad Autónoma de Bucaramanga