Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St Stephens Aids Trust
• Treatments: Maraviroc

Criteria

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