Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

Phase 3

Completed

• Conditions: HIV Infection; Cardiovascular Disease; HIV Infections; Inflammation
• Interventions: Drug: placebo; Drug: Maraviroc

• Registration Number: NCT00844519
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Study Start: 2010-01
• Primary Completion: 2012-12
• Results First Submitted: 2014-05-19
• Results First Submitted QC: 2014-05-19
• Study Completion: 2014-06
• Results First Posted: 2014-06-19
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-16
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Stable antiretroviral therapy for at least 12 months
2. 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.
3. Screening plasma HIV RNA levels < 50 copies RNA/mL
4. >90% adherence to therapy within the preceding 30 days, as determined by self-report
5. 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

1. Ongoing or prior use of any integrase inhibitor or R5 inhibitor.
2. Patients who plan to modify existing antiretroviral therapy in the next 24 weeks for any reason
3. Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
4. Concurrent or recent exposure to any immunomodulatory drugs
5. Advanced liver disease or active hepatitis B or C
6. Patients with systolic blood pressure <100/70
7. Starting or stopping statin therapy during the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Maraviroc	Maraviroc	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.

Primary Outcome Measures

Name	Time	Method
Percent Change in FMD	Baseline, 24 weeks	endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States