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

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.

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Key information

Conditions

Chagas Disease Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Trypanosomiasis Vector Borne Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Posaconazole

Drug

POS 40 mg/mL oral suspension

Other names: SCH 056592, MK-5592

Placebo for posaconazole

Drug

Placebo oral suspension

Benznidazole

Drug

BNZ 100 mg oral tablet

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Acronym: STOP CHAGAS

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2015
First posted: Jun 21, 2011
Registry last updated: Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed