Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
W. Todd Cade, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01107834
First received: April 19, 2010
Last updated: June 8, 2016
Last verified: June 2016
Results First Received: December 16, 2013  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Cross-Sectional
Condition: HIV Infections

  Participant Flow
  Hide Participant Flow

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
Healthy Control HIV-negative children born to healthy, HIV-negative women
Exposed to HIV/HAART HIV-negative children exposed to HIV and HAART in utero

Participant Flow:   Overall Study
    Healthy Control     Exposed to HIV/HAART  
STARTED     30     30  
COMPLETED     30     30  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Healthy Control HIV-negative children born to healthy, HIV-negative women
Exposed to HIV/HAART HIV-negative children exposed to HIV and HAART in utero
Total Total of all reporting groups

Baseline Measures
    Healthy Control     Exposed to HIV/HAART     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: years]
Mean (Standard Deviation)
  8  (2)     8  (3)     8  (2)  
Gender  
[units: participants]
     
Female     11     11     22  
Male     19     19     38  
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     22     23     45  
White     6     6     12  
More than one race     2     1     3  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     30     30     60  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Left Ventricular Mass Index   [ Time Frame: Baseline ]

2.  Primary:   Fractional Shortening   [ Time Frame: Baseline ]

3.  Secondary:   Global Strain Rate   [ Time Frame: Baseline ]

4.  Secondary:   Systolic Myocardial Velocity During Systole (S')   [ Time Frame: Baseline ]

5.  Secondary:   Early to Late Diastolic Filling Ratio   [ Time Frame: Baseline ]

6.  Secondary:   Myocardial Wall Velocity During Early Diastole   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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
e-mail: tcade@wustl.edu


Publications of Results:

Responsible Party: W. Todd Cade, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01107834     History of Changes
Other Study ID Numbers: 10-0121
Study First Received: April 19, 2010
Results First Received: December 16, 2013
Last Updated: June 8, 2016
Health Authority: United States: Institutional Review Board