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Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00844519
First Posted: February 16, 2009
Last Update Posted: July 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Pfizer
Information provided by (Responsible Party):
University of California, San Francisco
Results First Submitted: May 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infection
Cardiovascular Disease
Inflammation
HIV Infections
Interventions: Drug: Maraviroc
Drug: placebo

  Participant Flow
  Hide Participant Flow

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
  Description
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 
NOT COMPLETED   2   1 
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
e-mail: phsue@medsfgh.ucsf.edu



Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00844519     History of Changes
Other Study ID Numbers: HIVCADRFA
First Submitted: February 13, 2009
First Posted: February 16, 2009
Results First Submitted: May 19, 2014
Results First Posted: June 19, 2014
Last Update Posted: July 24, 2014