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HIV and Kidney Function Study

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ClinicalTrials.gov Identifier: NCT00905151
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : February 6, 2017
Last Update Posted : March 15, 2017
Sponsor:
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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Other
Conditions HIV Infections
AIDS
Enrollment 206
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HIV Positive
Hide Arm/Group Description A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
Period Title: Overall Study
Started 206
Completed 200
Not Completed 6
Arm/Group Title HIV Positive
Hide Arm/Group Description A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
Overall Number of Baseline Participants 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
<=18 years
0
   0.0%
Between 18 and 65 years
194
  97.0%
>=65 years
6
   3.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Female
55
  27.5%
Male
145
  72.5%
1.Primary Outcome
Title Performance of Glomerular Filtration Rate (GFR) Estimating Equations
Hide Description Overall bias, median difference (95% confidence interval), mL/min per 1.73 m^2, assessed as the median difference between the measured and estimated GFR across all estimated GFR levels, with positive values indicating an underestimation of measured GFR.
Time Frame Blood samples for plasma iohexol clearance were taken at approximately 10, 30, 120, and 240 minutes post-iohexol dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Positive
Hide Arm/Group Description:
Across-sectional analysis of 200 HIV+ patients with varying levels of kidney function
Overall Number of Participants Analyzed 200
Median (95% Confidence Interval)
Unit of Measure: mL/min per 1.73 m^2
MDRD study
10.9
(8.0 to 14.0)
CKD-EPI creatinine
5.4
(2.7 to 7.9)
CKD-EPI cystatin C
4.3
(1.2 to 7.7)
CKD-EPI creatinin-cystatin
6.4
(3.1 to 9.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HIV Positive
Hide Arm/Group Description A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
All-Cause Mortality
HIV Positive
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HIV Positive
Affected / at Risk (%)
Total   0/206 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HIV Positive
Affected / at Risk (%)
Total   0/206 (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: Associate Professor
Organization: Tufts Medical Center
Phone: 617-636-2569
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