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HIV and Kidney Function Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00905151
First Posted: May 20, 2009
Last Update Posted: March 15, 2017
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.
Collaborators:
Icahn School of Medicine at Mount Sinai
University of Alabama at Birmingham
University of Minnesota - Clinical and Translational Science Institute
Gilead Sciences
Information provided by (Responsible Party):
Tufts Medical Center
Results First Submitted: July 27, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Other
Conditions: HIV Infections
AIDS

  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 Positive A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function

Participant Flow:   Overall Study
    HIV Positive
STARTED   206 
COMPLETED   200 
NOT COMPLETED   6 



  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 Positive A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function

Baseline Measures
   HIV Positive 
Overall Participants Analyzed 
[Units: Participants]
 200 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      194  97.0% 
>=65 years      6   3.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      55  27.5% 
Male      145  72.5% 


  Outcome Measures

1.  Primary:   Performance of Glomerular Filtration Rate (GFR) Estimating Equations   [ Time Frame: Blood samples for plasma iohexol clearance were taken at approximately 10, 30, 120, and 240 minutes post-iohexol dose. ]


  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:  
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: Associate Professor
Organization: Tufts Medical Center
phone: 617-636-2569
e-mail: linker@tuftsmedicalcenter.org


Publications of Results:
Other Publications:

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00905151     History of Changes
Other Study ID Numbers: IRB # 8761
First Submitted: May 15, 2009
First Posted: May 20, 2009
Results First Submitted: July 27, 2016
Results First Posted: February 6, 2017
Last Update Posted: March 15, 2017