HIV and Kidney Function Study

Completed

Conditions studied: HIV Infections, AIDS

In brief

Current methods to assess kidney function have not been tested in people who have HIV/AIDS population. Given effects of the disease as well as potential effects of the medications, it is possible that the methods currently used to assess kidney function are not accurate. This purpose of this study is to evaluate methods to assess kidney function the HIV population. The investigators hypothesize that tenofovir causes a decrease in the secretion of creatinine which would cause an elevation in blood levels without affecting actual glomerular filtration rate (GFR).

Key facts

Study ID: NCT00905151
Run by: Tufts Medical Center
People needed: 206
Starts: 2009-01-01
Expected to finish: 2010-06-01
Last updated by the study team: 2017-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female 18 years of age or older
Confirmed HIV positive status
Treatment with stable antiretroviral medications for a period of at least 3 months prior to the study

You may not qualify if…

Persons less than 18 years of age. Children are excluded due to the fact that they are still growing. Growth causes levels of creatinine to change differently than in adults, thus requiring the use of age-specific GFR estimating equations.
Women who are either pregnant or who intend to become pregnant during the period of time in which the study visits will occur.
Allergy to any of the contrast media used or a known allergy to iodine or shellfish. Subjects who are not sure if they have an iodine allergy because they have not eaten shellfish nor have never received contrast dye will be excluded from participation.
Inability to cease taking medications that affect creatinine levels (e.g. trimethoprim containing medications, cimetidine) for one week prior to the study visit
Inability to maintain stable regimen of non-steroidal anti-inflammatory agents, angiotension converting enzyme inhibitors and or angiotension receptor blockers for one week prior to study visit.
Women who are breastfeeding
Current treatment with amiodarone
Current treatment with metformin
Acute exacerbation of asthma or chronic obstructive lung disease in the past three months requiring hospitalization or oral steroid therapy
Inadequate venous access
People with kidney failure (currently undergoing or having received peritoneal dialysis or hemodialysis treatment within the past three months or estimated GFR (eGFR) < 15 ml/min per 1.73 m2)
End stage conditions such as cirrhosis
Active treatment for cancer
Progressive neurological diseases
Severe gastric immotility
History of cognitive or physical impairments that will not allow completion of the study
Inability to provide informed consent

Where it is running

Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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