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Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco Identifier:
First received: February 13, 2009
Last updated: July 16, 2014
Last verified: July 2014
Results First Received: May 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infection
Cardiovascular Disease
HIV Infections
Interventions: Drug: Maraviroc
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Maraviroc maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.
Placebo matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.

Participant Flow:   Overall Study
    Maraviroc   Placebo
STARTED   26   26 
COMPLETED   24   25 
Withdrawal by Subject                1                1 
Adverse Event                1                0 

  Baseline Characteristics

  Outcome Measures

1.  Primary:   Percent Change in FMD   [ Time Frame: Baseline, 24 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Priscilla Hsue
Organization: University of California San Francisco
phone: 415-206-8257

Responsible Party: University of California, San Francisco Identifier: NCT00844519     History of Changes
Other Study ID Numbers: HIVCADRFA
Study First Received: February 13, 2009
Results First Received: May 19, 2014
Last Updated: July 16, 2014