HIV Infections
Conditions
Brief summary
A placebo controlled study of the impact on insulin sensitivity and lipid profile of maraviroc 300 mg twice daily in HIV negative male volunteers.
Interventions
DRUGMaraviroc
Maraviroc 300 mg twice daily for the first 14 days of the study. Placebo twice daily for the last 14 days of the study
Sponsors
St Stephens Aids Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in insulin sensitivity by euglycaemic clamp method | two weeks |
Secondary
| Measure | 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 |
Countries
United Kingdom
Outcome results
None listed