Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

Last updated: July 16, 2014
Sponsor: University of California, San Francisco
Overall Status: Completed

Phase

3

Condition

Inflammation

Heart Disease

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT00844519
HIVCADRFA
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 (< 50copies 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 atscreening and agree to use a double-barrier method of contraception throughout thestudy period.

Exclusion

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 forany reason

  3. Serious illness requiring hospitalization or parental antibiotics within preceding 3months

  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

Total Participants: 52
Study Start date:
January 01, 2010
Estimated Completion Date:
June 30, 2014

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94110
    United States

    Site Not Available

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