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Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Maraviroc

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Chelsea and Westminster Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline in insulin sensitivity by euglycaemic clamp method

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

Full Information

NCT ID

NCT00771823

First Posted

July 28, 2008

Last Updated

August 13, 2010

Sponsor

St Stephens Aids Trust

1. Study Identification

Unique Protocol Identification Number

NCT00771823

Brief Title

Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

St Stephens Aids Trust

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Maraviroc

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Maraviroc

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in insulin sensitivity by euglycaemic clamp method

Time Frame

two weeks

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Graeme Moyle

Organizational Affiliation

St Stephen's AIDS Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chelsea and Westminster Hospital

City

London

ZIP/Postal Code

SW10 9TH

Country

United Kingdom

12. IPD Sharing Statement

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