Chagas disease
Conditions
Interventions
This is a randomized, non-blinded clinical study with six arms. The study aim is to assess a combination of drugs for Chagas disease (CD) therapy, assuming benznidazol (BZ) as the drug of choice plus
Sponsors
Fundação Oswaldo Cruz
Fundação Oswaldo Cruz
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Adults; aged from 18 to 75 years; both sexes; diagnosis of chronic Chagas disease in the indeterminate form or cardiac form at stage A or B1; two distinct serological tests (enzyme-linked immunosorbent assay and indirect immunofluorescence, immunochromatography, or chemiluminescence) positive for Chagas disease
Exclusion criteria
Exclusion criteria: Previous benznidazol (BZ) or dissulfiram (DF) treatment, contraindications or hypersensitivity; alcoholism; renal or hepatic impairment; gastrointestinal disorders; epileptic, haematological, or psychiatric disorders; pregnancy or lactation; heart disease associated with moderate or severe orovalvar disease, ischemic, congenital or hypertensive heart disease; systemic diseases such as diabetes, autoimmune disorders, cancer, other infectious diseases such as acquired immunodeficiency syndrome; use of any eventual medication within 7 days before starting study treatment, except for dipyrone and paracetamol; use of any antifungal 60 days before starting study treatment; previous intervention studies one year before; cognitive impairments that do not allow the correct understanding of the informed consent; use of any drug toxic to the main body organs within 3 months prior to the start of study treatment; women in childbearing age that refuse to use contraceptive drug; consumption of CYP450 enzyme inducing and/or inhibitory drugs, such as ketoconazole and other known strong CYP3A4 inhibitors, organotoxic or with a long half-life, within 4 weeks prior to the start of the study; consumption of enzyme-inducing and/or inhibitory drugs (P-gp); alcohol consumption in the 48 hours prior to admission to the study and throughout the study period; consumption of foods or drinks containing grapefruit within 7 days prior to admission to the study and throughout the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of toxicity (serious adverse events) caused by the combination of BZ and DF detected by clinical observation and blood tests in at least one third of the participants of a same study arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-treatment negative T. cruzi PCR in more than 80% of the participants of the study arm. | — |
Countries
Brazil
Contacts
Public ContactRoberto Saraiva
Fundação Oswaldo Cruz
Outcome results
None listed