Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
NCT ID: NCT01133210
Last Updated: 2013-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2011-01-31
2012-11-30
Brief Summary
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1. Plasma triglyceride concentration
2. Plasma HDL-cholesterol and LDL-cholesterol concentrations
3. Plasma markers of cardiometabolic risk and inflammation
Detailed Description
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1. Plasma triglyceride concentration
2. Plasma HDL-cholesterol and LDL-cholesterol concentrations
3. Plasma markers of cardiometabolic risk and inflammation
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Maraviroc
Subjects will receive 12 weeks of treatment with maraviroc (300 mg po bid).
Maraviroc
dosage will be a 300mg Maraviroc pill twice a day for 12 weeks
Placebo
Subjects will receive 12 weeks of treatment with placebo
placebo
subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.
Interventions
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Maraviroc
dosage will be a 300mg Maraviroc pill twice a day for 12 weeks
placebo
subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* increased plasma triglyceride concentrations (150-400 mg/dL)
Exclusion Criteria
* history of alcohol abuse
* current alcohol consumption (\>20g/day)
* severe hypertriglyceridemia (\>400 mg/dL)
* active peptic ulcer disease
* diabetes
* pregnant or lactating
* take statins, fibrates, niacin, moderate to strong Cyp3A4 inhibitors or inducers, or any other medication that might confound interpretation of the study results will be excluded.
18 Years
64 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Samuel Klein, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Other Identifiers
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10-0533
Identifier Type: -
Identifier Source: org_study_id