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Heart Function in HIV-Negative Children Exposed to HIV and HAART

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ClinicalTrials.gov Identifier: NCT01107834
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : July 20, 2016
Last Update Posted : July 20, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
W. Todd Cade, Washington University School of Medicine

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Cross-Sectional
Condition HIV Infections
Enrollment 60

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy Control Exposed to HIV/HAART
Hide Arm/Group Description HIV-negative children born to healthy, HIV-negative women HIV-negative children exposed to HIV and HAART in utero
Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title Healthy Control Exposed to HIV/HAART Total
Hide Arm/Group Description HIV-negative children born to healthy, HIV-negative women HIV-negative children exposed to HIV and HAART in utero Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
8  (2) 8  (3) 8  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
11
  36.7%
11
  36.7%
22
  36.7%
Male
19
  63.3%
19
  63.3%
38
  63.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 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
22
  73.3%
23
  76.7%
45
  75.0%
White
6
  20.0%
6
  20.0%
12
  20.0%
More than one race
2
   6.7%
1
   3.3%
3
   5.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Left Ventricular Mass Index
Hide Description left ventricular mass index measured by 2D echocardiography
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Control Exposed to HIV/HAART
Hide Arm/Group Description:
HIV-negative children born to healthy, HIV-negative women
HIV-negative children exposed to HIV and HAART in utero
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: g/m2
67  (12) 60  (9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Control, Exposed to HIV/HAART
Comments T-test to detect differences between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Fractional Shortening
Hide Description Fractional shortening measured by M-mode cardiography
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Control Exposed to HIV/HAART
Hide Arm/Group Description:
HIV-negative children born to healthy, HIV-negative women
HIV-negative children exposed to HIV and HAART in utero
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: percentage of full contraction
36  (5) 37  (7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Control, Exposed to HIV/HAART
Comments T-test to detect differences between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Global Strain Rate
Hide Description Myocardial deformation (a measure of heart contractility) measured by speckel tracking echocardiography
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Control Exposed to HIV/HAART
Hide Arm/Group Description:
HIV-negative children born to healthy, HIV-negative women
HIV-negative children exposed to HIV and HAART in utero
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: percentage of full deformation
-22.3  (3.2) -21.1  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Control, Exposed to HIV/HAART
Comments T-test to detect differences between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Systolic Myocardial Velocity During Systole (S')
Hide Description Systolic myocardial velocity during systole measured by tissue Doppler echocardiography
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Control Exposed to HIV/HAART
Hide Arm/Group Description:
HIV-negative children born to healthy, HIV-negative women
HIV-negative children exposed to HIV and HAART in utero
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: cm/s
9.3  (1.1) 9.1  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Control, Exposed to HIV/HAART
Comments T-test to detect differences between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Early to Late Diastolic Filling Ratio
Hide Description Early to late diastolic filling ratio measured by tissue Doppler echocardiography
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Control Exposed to HIV/HAART
Hide Arm/Group Description:
HIV-negative children born to healthy, HIV-negative women
HIV-negative children exposed to HIV and HAART in utero
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: ratio, unitless
2.1  (0.5) 1.8  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Control, Exposed to HIV/HAART
Comments T-test to detect differences between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Myocardial Wall Velocity During Early Diastole
Hide Description Myocardial wall velocity during early diastolemeasured by tissue Doppler imaging
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Control Exposed to HIV/HAART
Hide Arm/Group Description:
HIV-negative children born to healthy, HIV-negative women
HIV-negative children exposed to HIV and HAART in utero
Overall Number of Participants Analyzed 30 30
Mean (Standard Error)
Unit of Measure: cm/s
16.3  (2.5) 15.0  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Control, Exposed to HIV/HAART
Comments T-test to detect differences between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Control Exposed to HIV/HAART
Hide Arm/Group Description

HIV-negative children born to healthy, HIV-negative women

No adverse events

HIV-negative children exposed to HIV and HAART in utero

No adverse events

All-Cause Mortality
Healthy Control Exposed to HIV/HAART
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Control Exposed to HIV/HAART
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Control Exposed to HIV/HAART
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
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: William T. Cade
Organization: Washington University
Phone: 314-286-1432
Responsible Party: W. Todd Cade, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01107834     History of Changes
Other Study ID Numbers: 10-0121
First Submitted: April 19, 2010
First Posted: April 21, 2010
Results First Submitted: December 16, 2013
Results First Posted: July 20, 2016
Last Update Posted: July 20, 2016