A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267) (STOP CHAGAS)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Chagas Disease

Treatments: Drug: Posaconazole; Drug: Placebo for posaconazole; Drug: Benznidazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01377480

P05267

MK-5592-055 (Other Identifier)

Details and patient eligibility

About

This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg twice daily improves therapeutic response compared to placebo in participants with a diagnosis of asymptomatic chronic Chagas disease.

Enrollment: 120 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have a positive serology result for Trypanosoma cruzi on any 2 of 3 of the following tests: indirect immunofluorescence, indirect hemagglutination, or enzyme-linked immunoabsorbent assay (ELISA)

• Must have a positive qualitative polymerase chain reaction (PCR) for Trypanosoma cruzi
• Must have a normal 12-lead electrocardiogram (ECG)
• Must have a normal 2-D echocardiogram
• Must have no evidence of ventricular tachycardia on 24-hour Holter monitoring
• Female participants of childbearing age must be using a medically accepted method of birth control before beginning study drug treatment and must agree to continue its use during the study, or must have been surgically sterilized
• Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline or within 72 hours before the start of study drug

Exclusion criteria

• Are breastfeeding, pregnant, or planning to become pregnant
• Body weight <60 kg
• Have an immunodeficiency or are immunosuppressed
• History of megacolon with obstipation or megaesophagus with severe swallowing impairment.
• Have previously received treatment with benznidazole or nifurtimox
• Known allergy/sensitivity to azoles
• Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 2.5 times the upper limit of normal at Screening
• Has serum creatinine >2.5 mg/dL or 200 micromoles at Screening
• Has a history of severe alcohol abuse within two years from Screening
• Is taking any of the prohibited medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups, including a placebo group

Posaconazole

Experimental group

Description:

Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days

Treatment:

Drug: Posaconazole

Placebo

Placebo Comparator group

Description:

Posaconazole placebo (10 mL) oral suspension twice daily for 60 days

Treatment:

Drug: Placebo for posaconazole

Posaconazole + Benznidazole

Experimental group

Description:

Posaconazole 400 mg (10 mL) oral suspension twice daily for 60 days and benznidazole (BNZ) 100 mg oral tablet twice daily (200-mg daily dose) for 60 days

Treatment:

Drug: Benznidazole

Drug: Posaconazole

Benznidazole + Placebo

Active Comparator group

Description:

Posaconazole placebo (10 mL) oral suspension twice daily for 60 days and benznidazole 100 mg oral tablet twice daily (200-mg daily dose) for 60 days

Treatment:

Drug: Placebo for posaconazole

Drug: Benznidazole