Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the potentially beneficial aspects of CCR5 inhibition on inflammation and endothelial function as measured by brachial artery reactivity in antiretroviral treated HIV patients with an undetectable viral load.

Conditions
-----------------
HIV Infection, Cardiovascular Disease, Inflammation, HIV Infections

Intervention / Treatment
-----------------
* Drug: Maraviroc
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable antiretroviral therapy for at least 12 months All plasma HIV RNA levels within the past year must be below level of detection (< 50 copies RNA/mL), although isolated single values > 50 but < 200 copies will be allowed. Screening plasma HIV RNA levels < 50 copies RNA/mL >90% adherence to therapy within the preceding 30 days, as determined by self-report Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period. Exclusion Criteria: Ongoing or prior use of any integrase inhibitor or R5 inhibitor. Patients who plan to modify existing antiretroviral therapy in the next 24 weeks for any reason Serious illness requiring hospitalization or parental antibiotics within preceding 3 months Concurrent or recent exposure to any immunomodulatory drugs Advanced liver disease or active hepatitis B or C Patients with systolic blood pressure <100/70 Starting or stopping statin therapy during the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Maraviroc<br>For subjects assigned to the maraviroc group, subjects will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medication. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily. | Drug: Maraviroc<br>* For subjects assigned to the maraviroc group, they will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications. For subjects on ritonavir, the dose will be reduced to 150mg by mouth twice daily for 24 weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* For subjects assigned to the placebo group, they will receive a matching placebo pill 300mg to be taken by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in FMD | endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery | Baseline, 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Experienced, CCR5 receptor, maraviroc