Evaluation of Albuminuria HIV-Infected Patients (NCT00524992) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Albuminuria HIV-Infected Patients
United States252 participantsStarted 2007-08-29
Plain-language 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.
Who can participate
Age range
8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* HIV+ adults and children greater than 8 years of age
EXCLUSION CRITERIA:
* Inability or unwillingness to give consent or assent or to comply with study requirements
* Unable to return to NIH or Washington Hospital Center for two follow-up visits over a 9-month period
* New opportunistic or bacterial infection within past 3 months or active opportunistic infection.
* Active malignancy, other than non-melanoma skin cancer and cutaneous Kaposi sarcoma not requiring treatment. Rationale: systemic inflammation may induce microalbuminuria.
* Diabetes by history
* IL-2, IL-7 or IFN-alpha therapy within past 3 months. Rationale: IL-2 and IFN-alpha therapy induce renal dysfunction and IL-7 may be associated with systemic inflammation.
* Non compliance, alcohol use, and drug use are conditions that make study completion unlikely or difficult.
* Diabetes (fasting glucose greater than 125 mg/dL or 2 hour oral glucose tolerance value greater than or equal to 200 mg/dL or current diagnosis of diabetes).
* Serum creatinine greater than 1.4 mg/dL.
* Urine protein/creatinine ratio greater than 0.5 and sustained on at least 2 measurements.
* Pregnant Women
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00524992
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)