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Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00771823
First Posted: October 15, 2008
Last Update Posted: August 16, 2010
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.
Information provided by:
St Stephens Aids Trust
July 28, 2008
October 15, 2008
August 16, 2010
May 2008
November 2008   (Final data collection date for primary outcome measure)
Change from baseline in insulin sensitivity by euglycaemic clamp method [ Time Frame: two weeks ]
Same as current
Complete list of historical versions of study NCT00771823 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers
A Placebo Controlled Study of the Impact on Insulin Sensitivity and Lipid Profile of Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers
A placebo controlled study of the impact on insulin sensitivity and lipid profile of maraviroc 300 mg twice daily in HIV negative male volunteers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
HIV Infections
  • 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
  • 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: 2
    Intervention: Drug: Maraviroc
  • 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
    Intervention: Drug: Maraviroc
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
November 2008
November 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00771823
SSAT025
2007-004477-25 ( EudraCT Number )
No
Not Provided
Not Provided
Dr Graeme Moyle, St Stephen's AIDS Trust
St Stephens Aids Trust
Not Provided
Principal Investigator: Graeme Moyle St Stephen's AIDS Trust
St Stephens Aids Trust
August 2010

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