Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

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

Official Title
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A Placebo Controlled Study of the Impact on Insulin Sensitivity and Lipid Profile of Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Maraviroc
* Drug: Maraviroc


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br> | Drug: Maraviroc<br>* Placebo twice daily for the first 14 days of the study. Maraviroc 300 mg twice daily for the last 14 days of the study.<br>|
| Active Comparator: 1<br>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<br>* Maraviroc 300 mg twice daily for the first 14 days of the study. Placebo twice daily for the last 14 days of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in insulin sensitivity by euglycaemic clamp method |  | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | two weeks |