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

NCT ID: NCT01377480

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-06
• Study Completion Date: 2015-01-12

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.

Conditions

Chagas Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Posaconazole

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

Group Type: EXPERIMENTAL

Posaconazole

Intervention Type: DRUG

POS 40 mg/mL oral suspension

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo for posaconazole

Intervention Type: DRUG

Placebo oral suspension

Posaconazole + 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

Group Type: EXPERIMENTAL

Posaconazole

Intervention Type: DRUG

POS 40 mg/mL oral suspension

Benznidazole

Intervention Type: DRUG

BNZ 100 mg oral tablet

Benznidazole + Placebo

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

Group Type: ACTIVE_COMPARATOR

Placebo for posaconazole

Intervention Type: DRUG

Placebo oral suspension

Benznidazole

Intervention Type: DRUG

BNZ 100 mg oral tablet

Interventions

Posaconazole

POS 40 mg/mL oral suspension

Intervention Type: DRUG

Placebo for posaconazole

Placebo oral suspension

Intervention Type: DRUG

Benznidazole

BNZ 100 mg oral tablet

Intervention Type: DRUG

Other Intervention Names

SCH 056592, MK-5592

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Morillo CA, Waskin H, Sosa-Estani S, Del Carmen Bangher M, Cuneo C, Milesi R, Mallagray M, Apt W, Beloscar J, Gascon J, Molina I, Echeverria LE, Colombo H, Perez-Molina JA, Wyss F, Meeks B, Bonilla LR, Gao P, Wei B, McCarthy M, Yusuf S; STOP-CHAGAS Investigators. Benznidazole and Posaconazole in Eliminating Parasites in Asymptomatic T. Cruzi Carriers: The STOP-CHAGAS Trial. J Am Coll Cardiol. 2017 Feb 28;69(8):939-947. doi: 10.1016/j.jacc.2016.12.023.

Reference Type: RESULT

PMID: 28231946 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

MK-5592-055

Identifier Type: OTHER

Identifier Source: secondary_id

P05267

Identifier Type: -

Identifier Source: org_study_id