Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771823
• Other study ID #: SSAT025
• Secondary ID: 2007-004477-25
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2008
• Last updated: August 13, 2010
• Start date: May 2008
• Est. completion date: November 2008

Study information

• Verified date: August 2010
• Source: St Stephens Aids Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• 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
• Maraviroc
Placebo twice daily for the first 14 days of the study. Maraviroc 300 mg twice daily for the last 14 days of the study.

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
St Stephens Aids Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in insulin sensitivity by euglycaemic clamp method		two weeks	Yes
Secondary	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	Yes