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Completed

NCT Number: NCT01133210

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

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

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Maraviroc

Drug

dosage will be a 300mg Maraviroc pill twice a day for 12 weeks

Other names: Selzentry, Celsentri

Placebo

Other

subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.

Other names: control

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 28, 2010
Registry last updated
Dec 10, 2013

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.

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