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Completed

NCT Number: NCT00771823

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chelsea and Westminster Hospital

London, SW10 9TH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Maraviroc

Drug

Maraviroc 300 mg twice daily for the first 14 days of the study. Placebo twice daily for the last 14 days of the study

Primary outcomes

  1. Change from baseline in insulin sensitivity by euglycaemic clamp method

    Time frame: two weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

St Stephens Aids Trust

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 15, 2008
Registry last updated
Aug 16, 2010

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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