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Clinical Trials

MainTitle

Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

This study has been completed
Sponsor
St Stephens Aids Trust


Information provided by (Responsible Party)
St Stephens Aids Trust
ClinicalTrials.gov Identifier
NCT00771823

First received: July 28, 2008
Last updated: August 13, 2010
Last Verified: August 2010
History of Changes
Purpose

Purpose

A placebo controlled study of the impact on insulin sensitivity and lipid profile of maraviroc 300 mg twice daily in HIV negative male volunteers.

Condition Intervention Phase
HIV Infections

Drug : Maraviroc
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by St Stephens Aids Trust:

Primary Outcome Measures

  • Change from baseline in insulin sensitivity by euglycaemic clamp method [ Time Frame: two weeks ]
Secondary Outcome Measures:
  • 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 [ Time Frame: two weeks ]

Enrollment: 16
Study Start Date: May 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: 2

Drug: 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.

Active Comparator: 1
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

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 60 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771823

Locations

United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9TH

Sponsors and Collaborators

St Stephens Aids Trust

Investigators

Principal Investigator: Graeme Moyle St Stephen's AIDS Trust
More Information

More Information


Responsible Party: Dr Graeme Moyle, St Stephen's AIDS Trust  
ClinicalTrials.gov Identifier: NCT00771823   History of Changes  
Other Study ID Numbers: SSAT025  
  2007-004477-25  
Study First Received: July 28, 2008  
Last Updated: August 13, 2010  

Additional relevant MeSH terms:
HIV Infections
Maraviroc

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.