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Trial record 1 of 1 for:    NCT01133210
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Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)

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.
 
ClinicalTrials.gov Identifier: NCT01133210
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : December 10, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE May 26, 2010
First Posted Date  ICMJE May 28, 2010
Last Update Posted Date December 10, 2013
Study Start Date  ICMJE January 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
effect of Maraviroc on plasma triglyceride concentration [ Time Frame: 12 weeks ]
We will compare pre and post-treatment serum triglyceride concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
  • Effect of Maraviroc on serum HDL concentration [ Time Frame: 12 weeks ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
Official Title  ICMJE Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
Brief Summary

The purpose of this study is to determine the effect of maraviroc therapy in obese insulin resistant subjects on:

  1. Plasma triglyceride concentration
  2. Plasma HDL-cholesterol and LDL-cholesterol concentrations
  3. Plasma markers of cardiometabolic risk and inflammation
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:

  1. Plasma triglyceride concentration
  2. Plasma HDL-cholesterol and LDL-cholesterol concentrations
  3. Plasma markers of cardiometabolic risk and inflammation
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hypertriglyceridemia
Intervention  ICMJE
  • Drug: Maraviroc
    dosage will be a 300mg Maraviroc pill twice a day for 12 weeks
    Other Names:
    • Selzentry
    • Celsentri
  • Other: placebo
    subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.
    Other Name: control
Study Arms  ICMJE
  • Experimental: Maraviroc
    Subjects will receive 12 weeks of treatment with maraviroc (300 mg po bid).
    Intervention: Drug: Maraviroc
  • Placebo Comparator: Placebo
    Subjects will receive 12 weeks of treatment with placebo
    Intervention: Other: placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2013)
27
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2010)
44
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01133210
Other Study ID Numbers  ICMJE 10-0533
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Samuel Klein, M.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date December 2013

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