Back to resultsEffect of Maraviroc on Endothelial Function in HIV-Infected Patients
Primary Purpose
HIV Infection, Cardiovascular Disease, Inflammation
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Maraviroc
placebo
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring Treatment Experienced, CCR5 receptor, maraviroc
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
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Maraviroc
Placebo
Arm Description
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.
Outcomes
Primary Outcome Measures
Percent Change in FMD
endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery
Secondary Outcome Measures
Full Information
NCT ID
NCT00844519
First Posted
February 13, 2009
Last Updated
July 16, 2014
Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00844519
Brief Title
Effect of Maraviroc on Endothelial Function in HIV-Infected Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Cardiovascular Disease, Inflammation, HIV Infections
Keywords
Treatment Experienced, CCR5 receptor, maraviroc
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Maraviroc
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Maraviroc
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change in FMD
Description
endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery
Time Frame
Baseline, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Maraviroc on Endothelial Function in HIV-Infected Patients
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