Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: Maraviroc

• Registration Number: NCT00771823
• Lead Sponsor: St Stephens Aids Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-07-28
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-13
• Last Update Posted: 2010-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Maraviroc	-
1	Maraviroc	* 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 Outcome Measures

Name	Time	Method
Change from baseline in insulin sensitivity by euglycaemic clamp method	two weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chelsea and Westminster Hospital; 🇬🇧 London, United Kingdom