Status:
COMPLETED
Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers
Lead Sponsor:
St Stephens Aids Trust
Conditions:
HIV Infections
Eligibility:
MALE
18-60 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00771823
Start Date
May 1 2008
End Date
November 1 2008
Last Update
August 16 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chelsea and Westminster Hospital
London, London, United Kingdom, SW10 9TH