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Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

This study has been completed.
Sponsor:
Information provided by:
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT00771823
First received: July 28, 2008
Last updated: August 13, 2010
Last verified: August 2010
History of Changes
  Purpose

A placebo controlled study of the impact on insulin sensitivity and lipid profile of maraviroc 300 mg twice daily in HIV negative male volunteers.


Condition Intervention Phase
HIV Infections
 Drug: Maraviroc
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo Controlled Study of the Impact on Insulin Sensitivity and Lipid Profile of Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

Resource links provided by NLM:

Drug Information available for: Maraviroc
U.S. FDA Resources

Further study details as provided by St Stephens Aids Trust:

Primary Outcome Measures:
  • Change from baseline in insulin sensitivity by euglycaemic clamp method [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in serum levels of fasting cholesterol, triglycerides Changes in serum biomarkers of vascular inflammation and in CD36 PMBC and other related markers gene expression [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: May 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 Drug: Maraviroc
  • Placebo twice daily for the first 14 days of the study.
  • Maraviroc 300 mg twice daily for the last 14 days of the study.
Active Comparator: 1
  • Maraviroc 300 mg twice daily for the first 14 days of the study.
  • Placebo twice daily for the last 14 days of the study
 Drug: Maraviroc
Maraviroc 300 mg twice daily for the first 14 days of the study. Placebo twice daily for the last 14 days of the study

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must have documented negative HIV serology by ELISA and P24 antigen
  • Subjects must be clinically well males aged between 18 to 60 years.
  • Fasting blood glucose, total cholesterol and triglycerides within normal limits
  • Hepatic transaminases (AST and ALT) ≤ 3 × upper limit of normal (ULN)
  • Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm3; platelets ≥ 50,000/mm3; hemoglobin ≥ 8.0 g/dL)
  • Serum amylase ≤ 1.5 × ULN
  • Sexually active males must use condoms during the course of the study
  • Life expectancy ≥ 1 year
  • Willing and able to provide informed consent

Exclusion Criteria:

  • Subjects with a waist hip ratio > 0.97 or BMI > 28 kg/m2 will be excluded
  • Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit)
  • Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit)
  • Other metabolic syndrome or disease process in the opinion of the investigator likely to cause marked disturbance in glucose and lipid homeostasis including hypertension.

  • Receiving on-going therapy with any of the following:

    • Metabolically active medications
    • Any lipid-lowering medication
    • Hormonal agents (oestrogens or androgens)
    • Glucocorticoids
    • Beta-blockers
    • Thiazide diuretics
    • Thyroid preparations
    • Psychotropic agents
    • Anabolic steroids
    • Megestrol acetate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771823

Locations
United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9TH
Sponsors and Collaborators
St Stephens Aids Trust
Investigators
Principal Investigator: Graeme Moyle St Stephen's AIDS Trust
  More Information

No publications provided

Responsible Party: Dr Graeme Moyle, St Stephen's AIDS Trust
ClinicalTrials.gov Identifier: NCT00771823     History of Changes
Other Study ID Numbers: SSAT025, 2007-004477-25
Study First Received: July 28, 2008
Last Updated: August 13, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 21, 2013