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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Samir K Gupta, MD, MS, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00919724
First received: June 11, 2009
Last updated: July 1, 2014
Last verified: July 2014
Results First Received: May 28, 2014  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: HIV Infection

  Participant Flow


  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.
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
Total Total of all reporting groups

Baseline Measures
    HIV-Infected     HIV-Uninfected     Total  
Number of Participants  
[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 ]


  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


No publications provided


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, HL095149
Study First Received: June 11, 2009
Results First Received: May 28, 2014
Last Updated: July 1, 2014
Health Authority: United States: Federal Government