Evaluation of Albuminuria HIV-Infected Patients
Prospective Evaluation of Albuminuria in HIV Positive Patients
Other study identifiers
Sponsor study identifier
Secondary identifiers
observational
252
1 country
2
Study Start
August 29, 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 24, 2014
Date type not reportedThis date has not been verified as actual or estimated.
Brief Summary
This study will examine the following: 1) how common albuminuria and proteinuria are among HIV-positive patients, 2) what causes albuminuria or proteinuria in these patients and 3) whether the condition becomes more severe over time. HIV-infected people are more likely than others to develop kidney disease. The earliest indicator of the possible presence of kidney disease is albuminuria (increased amounts of the protein albumin in the urine). A later indicator is the appearance of other proteins, a condition called proteinuria. HIV-infected patients 8 years of age and older who do not have diabetes, chronic kidney disease or cancer may be eligible for this study. Participants provide a urine sample during three visits as follows: the first upon enrollment in the study, a second 3 months later, and a third about 6 months after that. Blood samples are drawn at the first and last visits. At the first visit a medical history is taken and blood pressure, height, weight, waist circumference, hip circumference and upper arm skin thickness are measured. Participants who are found to have albuminuria or proteinuria are asked to undergo a kidney biopsy for research purposes. The procedure is optional. Participants who develop heavy proteinuria may be recommended to undergo a kidney biopsy in order to determine the nature of the kidney disease and begin treatment. The biopsy requires a 2-day hospital stay. For the procedure, an anesthetic is given to numb the skin and a needle is inserted and guided into the kidney to withdraw a small tissue sample. The needle is passed twice, and possibly three times. Following the procedure, the subject remains in bed rest for at least 10 hours to minimize the risk of excessive bleeding.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 252 participants
- Study completion date
December 24, 2014
Date type not reportedThis date has not been verified as actual or estimated.
- Listed locations
- 1 countries · 2 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
August 29, 2007
Date type not reportedThis date has not been verified as actual or estimated.
First Submitted
September 1, 2007
Actual (reported)First Posted
September 5, 2007
Actual (reported)Study Completion
December 24, 2014
Date type not reportedThis date has not been verified as actual or estimated.
- Last Updated
- April 5, 2018
- Status Verified
- December 24, 2014
- Last Update Submitted
- April 4, 2018