Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

NCT00771823 | Completed Phase 1

• 2 other identifiers: SSAT0252007-004477-25
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Change from baseline in insulin sensitivity by euglycaemic clamp method

  two weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

2

ACTIVE COMPARATOR

Drug: Maraviroc

1

ACTIVE COMPARATOR

* Maraviroc 300 mg twice daily for the first 14 days of the study. * Placebo twice daily for the last 14 days of the study

Drug: Maraviroc

Interventions

Maraviroc DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Stephens Aids Trust: lead

Study Sites (1)

Chelsea and Westminster Hospital

London, London, SW10 9TH, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Graeme Moyle

  St Stephen's AIDS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: October 15, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

GB (1)