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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01377480
First Posted: June 21, 2011
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Chagas Disease Drug: Posaconazole Drug: Placebo for posaconazole Drug: Benznidazole Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Proof-of-Activity Study of Oral Posaconazole in the Treatment of Asymptomatic Chronic Chagas Disease (Phase 2, Protocol No. P05267)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction [ Time Frame: 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.


Enrollment: 120
Actual Study Start Date: July 6, 2011
Study Completion Date: January 12, 2015
Primary Completion Date: July 22, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Posaconazole
Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days
Drug: Posaconazole
POS 40 mg/mL oral suspension
Other Name: SCH 056592, MK-5592
Placebo Comparator: Placebo
Posaconazole placebo (10 mL) oral suspension twice daily for 60 days
Drug: Placebo for posaconazole
Placebo oral suspension
Experimental: 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
Drug: Posaconazole
POS 40 mg/mL oral suspension
Other Name: SCH 056592, MK-5592
Drug: Benznidazole
BNZ 100 mg oral tablet
Active Comparator: 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
Drug: Placebo for posaconazole
Placebo oral suspension
Drug: Benznidazole
BNZ 100 mg oral tablet

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377480


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01377480     History of Changes
Other Study ID Numbers: P05267
MK-5592-055 ( Other Identifier: Merck Protocol Number )
First Submitted: May 13, 2011
First Posted: June 21, 2011
Results First Submitted: July 13, 2015
Results First Posted: August 10, 2015
Last Update Posted: May 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Posaconazole
Benzonidazole
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors