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

NCT01377480 | Completed Phase 2 Results DMC

• 2 other identifiers: P05267MK-5592-055
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction

  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.

  Day 180

Study Arms (4)

Posaconazole

EXPERIMENTAL

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

Drug: Posaconazole

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo for posaconazole

Posaconazole + Benznidazole

EXPERIMENTAL

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

Drug: Posaconazole; Drug: Benznidazole

Benznidazole + Placebo

ACTIVE COMPARATOR

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

Drug: Placebo for posaconazole; Drug: Benznidazole

Interventions

Posaconazole DRUG

POS 40 mg/mL oral suspension

Also known as: SCH 056592, MK-5592

Posaconazole; Posaconazole + Benznidazole

Placebo for posaconazole DRUG

Placebo oral suspension

Benznidazole + Placebo; Placebo

Benznidazole DRUG

BNZ 100 mg oral tablet

Benznidazole + Placebo; Posaconazole + Benznidazole

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 28231946 RESULT

MeSH Terms

Conditions

Chagas Disease

Interventions

posaconazole; benzonidazole

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme, Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: June 21, 2011
• Study Start: July 6, 2011
• Primary Completion: July 22, 2014
• Study Completion: January 12, 2015
• Last Updated: August 27, 2018
• Results First Posted: August 10, 2015

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share