Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00844519
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 (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infection
Cardiovascular Disease
Inflammation
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
per protocol

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 was 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.
Total Total of all reporting groups

Baseline Measures
    Maraviroc     Placebo     Total  
Number of Participants  
[units: participants]
  26     26     52  
Age  
[units: years]
Median ( Inter-Quartile Range )
  52  
  ( 45 to 60 )  
  52  
  ( 47 to 57 )  
  52  
  ( 45 to 59 )  
Gender  
[units: participants]
     
Female     1     0     1  
Male     25     26     51  
Region of Enrollment  
[units: participants]
     
United States     26     26     52  



  Outcome Measures

1.  Primary:   Percent Change in FMD   [ Time Frame: Baseline, 24 weeks ]
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Measure Type Primary
Measure Title Percent Change in FMD
Measure Description endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery
Time Frame Baseline, 24 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Maraviroc maraviroc 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 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.

Measured Values
    Maraviroc     Placebo  
Number of Participants Analyzed  
[units: participants]
  26     26  
Percent Change in FMD  
[units: percent change in FMD]
Mean ± Standard Deviation
  0.57  ± 2.1     -0.05  ± 2.1  


Statistical Analysis 1 for Percent Change in FMD
Groups [1] Maraviroc
Method [2] t-test, 2 sided
P Value [3] 0.17
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  within-arm, pre-post change in FMD
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  significant at p<0.05

Statistical Analysis 2 for Percent Change in FMD
Groups [1] Placebo
Method [2] t-test, 2 sided
P Value [3] 0.90
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  within-arm, pre-post change in FMD
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  significant at p<0.05




  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


No publications provided


Responsible Party: University of California, San Francisco
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board