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

July 28, 2008
August 13, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 Blind (Subject, 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
Male
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00771823
SSAT025, 2007-004477-25
No
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