Status:
COMPLETED
Effect of Maraviroc on Endothelial Function in HIV-Infected Patients
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Pfizer
Conditions:
HIV Infection
Cardiovascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00844519
Start Date
January 1 2010
End Date
June 1 2014
Last Update
July 24 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Francisco
San Francisco, California, United States, 94110