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Comparing Blood Vessel Endothelial Function in HIV-Infected People and Matched HIV-Uninfected People

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00919724
First Posted: June 12, 2009
Last Update Posted: July 15, 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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Samir K Gupta, MD, MS, National Heart, Lung, and Blood Institute (NHLBI)
Results First Submitted: May 28, 2014  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: HIV Infection

  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
  Description
HIV-Infected HIV-infected participants who are not currently receiving antiretroviral medications
HIV-Uninfected HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants

Participant Flow:   Overall Study
    HIV-Infected   HIV-Uninfected
STARTED   45   44 
COMPLETED   45   44 
NOT COMPLETED   0   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.
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Reporting Groups
  Description
HIV-Infected HIV-infected participants who are not currently receiving antiretroviral medications
HIV-Uninfected HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
Total Total of all reporting groups

Baseline Measures
   HIV-Infected   HIV-Uninfected   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   44   89 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 35 
 (27 to 44) 
 35 
 (25 to 45) 
 35 
 (26 to 45) 
Gender 
[Units: Participants]
     
Female   10   11   21 
Male   35   33   68 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   28   14   42 
White   17   30   47 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 


  Outcome Measures

1.  Primary:   Endothelial Function (Brachial Artery Reactivity)   [ Time Frame: Single measurement ]
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Measure Type Primary
Measure Title Endothelial Function (Brachial Artery Reactivity)
Measure Description The maximum change in brachial artery diameter after induction of reactive hyperemia post-release of vascular occlusion. This is a measure of the ability of the endothelium to respond appropriately to lack of tissue oxygenation distal to the point of brachial artery compression.
Time Frame Single measurement  

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
HIV-Infected HIV-infected participants who are not currently receiving antiretroviral medications
HIV-Uninfected HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants

Measured Values
   HIV-Infected   HIV-Uninfected 
Participants Analyzed 
[Units: Participants]
 45   44 
Endothelial Function (Brachial Artery Reactivity) 
[Units: Percent dilation]
Mean (Standard Deviation)
 3.98  (2.95)   3.37  (2.74) 


Statistical Analysis 1 for Endothelial Function (Brachial Artery Reactivity)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Regression, Linear
P Value [4] 0.10
Mean Difference (Final Values) [5] 0.99
Standard Error of the mean (0.60)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
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[3] Other relevant method information, such as adjustments or degrees of freedom:
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[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Comparison between HIV-infected and HIV-uninfected groups. Comparison adjusted for age, gender, race, height, and brachial artery baseline diameter.
[5] Other relevant estimation information:
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  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Samir K. Gupta, MD, MS
Organization: Indiana University School of Medicine
phone: 317-274-7926
e-mail: sgupta1@iu.edu



Responsible Party: Samir K Gupta, MD, MS, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00919724     History of Changes
Other Study ID Numbers: 661
R01HL095149 ( U.S. NIH Grant/Contract )
HL095149
First Submitted: June 11, 2009
First Posted: June 12, 2009
Results First Submitted: May 28, 2014
Results First Posted: June 30, 2014
Last Update Posted: July 15, 2014