A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267 AM1) (STOP CHAGAS)

This study is currently recruiting participants.

Verified March 2013 by Merck

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01377480

First received: May 13, 2011

Last updated: March 22, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 13, 2011

Last Updated Date

March 22, 2013

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of participants with a reduction of parasitemia as measured by qualitative polymerase chain reaction (PCR) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01377480 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267 AM1)

Official Title ^ICMJE

Phase 2 Proof-of-Activity Study of Oral Posaconazole in the Treatment of Asymptomatic Chronic Chagas Disease (Phase 2, Protocol No. P05267)

Brief Summary

This is a study to compare the efficacy of Oral Posaconazole (POS) to placebo for the treatment of asymptomatic Chagas disease.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Chagas Disease

Intervention ^ICMJE

Drug: Posaconazole
10 mL orally twice daily for 60 days

Other Name: SCH 056592
Drug: Placebo for posaconazole
10 mL orally twice daily for 60 days
Drug: Benznidazole
200 mg orally twice daily for 60 days

Study Arm (s)

Experimental: Posaconazole
Intervention: Drug: Posaconazole
Placebo Comparator: Posaconazole Placebo
Intervention: Drug: Placebo for posaconazole
Experimental: Posaconazole + Benznidazole
Interventions:
- Drug: Posaconazole
- Drug: Benznidazole
Active Comparator: Posaconazole Placebo+ Benznidazole
Interventions:
- Drug: Placebo for posaconazole
- Drug: Benznidazole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

160

Estimated Completion Date

January 2015

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Toll Free Number

1-888-577-8839

Location Countries ^ICMJE

Argentina, Chile, Colombia, Mexico

Administrative Information

NCT Number ^ICMJE

NCT01377480

Other Study ID Numbers ^ICMJE

P05267

Has Data Monitoring Committee

Yes

Responsible Party

Merck

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Merck

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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