Status:
COMPLETED
Effect of Raltegravir on Endothelial Function in HIV-Infected Patients
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Merck Sharp & Dohme LLC
Conditions:
HIV Infection
Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Recent studies suggest that HIV patients are at increased risk for cardiovascular events; however, the mechanisms underlying this increased risk remain unclear. Our group was one of the first to demon...
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.
- CD4\<350 cells/mm3 for at least one year ("immunologic non-responder") or CD4\>=350 cells/mm3 for at least one year ("immunologic responder").
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 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00843713
Start Date
January 1 2009
End Date
February 1 2014
Last Update
December 12 2018
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94110