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

Phase 2

Completed

• Conditions: Chagas Disease
• Interventions: Drug: Placebo for posaconazole; Drug: Posaconazole; Drug: Benznidazole

• Registration Number: NCT01377480
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-21
• Study Start: 2011-07-06
• Primary Completion: 2014-07-22
• Study Completion: 2015-01-12
• Results First Submitted: 2015-07-13
• Results First Submitted QC: 2015-07-13
• Results First Posted: 2015-08-10
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Benznidazole + Placebo	Placebo for posaconazole	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
Placebo	Placebo for posaconazole	Posaconazole placebo (10 mL) oral suspension twice daily for 60 days
Posaconazole	Posaconazole	Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days
Posaconazole + Benznidazole	Benznidazole	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
Benznidazole + Placebo	Benznidazole	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
Posaconazole + Benznidazole	Posaconazole	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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction	Day 180	Blood samples were collected for qualitative polymerase chain reaction (PCR) assay for Trypanosoma cruzi deoxyribonucleic acid (DNA). Successful response was defined as a negative qualitative PCR value at the Day 180 follow up visit.