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

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ClinicalTrials.gov Identifier: NCT00919724
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : June 30, 2014
Last Update Posted : July 15, 2014
Sponsor:
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)

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Condition HIV Infection
Enrollment 89
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HIV-Infected HIV-Uninfected
Hide Arm/Group Description HIV-infected participants who are not currently receiving antiretroviral medications HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
Period Title: Overall Study
Started 45 44
Completed 45 44
Not Completed 0 0
Arm/Group Title HIV-Infected HIV-Uninfected Total
Hide Arm/Group Description HIV-infected participants who are not currently receiving antiretroviral medications HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants Total of all reporting groups
Overall Number of Baseline Participants 45 44 89
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 45 participants 44 participants 89 participants
35
(27 to 44)
35
(25 to 45)
35
(26 to 45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 89 participants
Female
10
  22.2%
11
  25.0%
21
  23.6%
Male
35
  77.8%
33
  75.0%
68
  76.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 89 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
28
  62.2%
14
  31.8%
42
  47.2%
White
17
  37.8%
30
  68.2%
47
  52.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Endothelial Function (Brachial Artery Reactivity)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-Infected HIV-Uninfected
Hide Arm/Group Description:
HIV-infected participants who are not currently receiving antiretroviral medications
HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
Overall Number of Participants Analyzed 45 44
Mean (Standard Deviation)
Unit of Measure: percent dilation
3.98  (2.95) 3.37  (2.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV-Infected, HIV-Uninfected
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments Comparison between HIV-infected and HIV-uninfected groups. Comparison adjusted for age, gender, race, height, and brachial artery baseline diameter.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.60
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HIV-Infected HIV-Uninfected
Hide Arm/Group Description HIV-infected participants who are not currently receiving antiretroviral medications HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
All-Cause Mortality
HIV-Infected HIV-Uninfected
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HIV-Infected HIV-Uninfected
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/44 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HIV-Infected HIV-Uninfected
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/44 (0.00%) 
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
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