Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Washington University School of Medicine.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Washington University School of Medicine
Collaborator:
Pfizer
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01133210
First received: May 26, 2010
Last updated: April 11, 2011
Last verified: April 2011
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Purpose
The purpose of this study is to determine the effect of maraviroc therapy in obese insulin resistant subjects on:
- Plasma triglyceride concentration
- Plasma HDL-cholesterol and LDL-cholesterol concentrations
- Plasma markers of cardiometabolic risk and inflammation
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertriglyceridemia |
Drug: Maraviroc Other: placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I) |
Resource links provided by NLM:
Further study details as provided by Washington University School of Medicine:
Primary Outcome Measures:
- effect of Maraviroc on plasma triglyceride concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]We will compare pre and post-treatment serum triglyceride concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.
Secondary Outcome Measures:
- Effect of Maraviroc on serum HDL concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]We will compare pre and post-treatment serum HDL concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.
- effect of Maraviroc on serum LDL-cholesterol concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]We will compare pre and post-treatment serum LDL-cholesterol concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.
- Effect of Maraviroc on plasma markers of cardiometabolic risk and inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]We will compare pre and post-treatment plasma concentrations of C-reactive protein and InterLeukin-6 in subjects receiving a 12 week course of either Maraviroc or placebo.
| Estimated Enrollment: | 44 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Maraviroc
Subjects will receive 12 weeks of treatment with maraviroc (300 mg po bid).
|
Drug: Maraviroc
dosage will be a 300mg Maraviroc pill twice a day for 12 weeks
Other Names:
|
|
Placebo Comparator: Placebo
Subjects will receive 12 weeks of treatment with placebo
|
Other: placebo
subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.
Other Name: control
|
Detailed Description:
The purpose of this study is to determine, in obese insulin resistant subjects, the effect of maraviroc therapy, a selective antagonist of the human chemokine receptor CCR5, on:
- Plasma triglyceride concentration
- Plasma HDL-cholesterol and LDL-cholesterol concentrations
- Plasma markers of cardiometabolic risk and inflammation
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- obese (body mass index (BMI) between 30 and 45.9)
- increased plasma triglyceride concentrations (150-400 mg/dL)
Exclusion Criteria:
- active or previous infection with hepatitis B or C
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133210
Contacts
| Contact: Emily Jenkerson, B.A. | 314-362-1000 | jenkersone@WUSTL.EDU |
| Contact: Martha Hessler, B.A. | 314-362-8703 | mhessler@dom.wustl.edu |
Locations
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Martha Hessler, B.A. 314-362-8703 mhessler@dom.wustl.edu | |
| Contact: Gary Skolnick, B.S. 314-362-5292 gskolnic@wustl.edu | |
| Principal Investigator: Samuel Klein, MD | |
Sponsors and Collaborators
Washington University School of Medicine
Pfizer
Investigators
| Principal Investigator: | Samuel Klein, M.D. | Washington University School of Medicine |
More Information
No publications provided
| Responsible Party: | Samuel Klein, Primary Investigator, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01133210 History of Changes |
| Other Study ID Numbers: | 10-0533 |
| Study First Received: | May 26, 2010 |
| Last Updated: | April 11, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Washington University School of Medicine:
|
hypertriglyceridemia triglyceride cholesterol Maraviroc |
Additional relevant MeSH terms:
|
Hypertriglyceridemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013