Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)

December 9, 2013 updated by: Washington University School of Medicine

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Celsentri
  • Selzentry
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 Names:
  • control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Pfizer

Investigators

  • Principal Investigator: Samuel Klein, M.D., Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (Estimate)

May 28, 2010

Study Record Updates

Last Update Posted (Estimate)

December 10, 2013

Last Update Submitted That Met QC Criteria

December 9, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-0533

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertriglyceridemia

Clinical Trials on Maraviroc

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe