HIV and Kidney Function Study

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

Brief Summary:
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).

Condition or disease
HIV Infections AIDS

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Evaluation of the Performance of GFR Estimating Equations in HIV Positive Patients
Study Start Date : January 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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

Primary Outcome Measures :
  1. 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. ]
    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.

Biospecimen Retention:   Samples Without DNA
Whole and urine will be retained for future testing.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from hospital based practices as well as from the community.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00905151

United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Icahn School of Medicine at Mount Sinai
University of Alabama at Birmingham
University of Minnesota - Clinical and Translational Science Institute
Gilead Sciences
Principal Investigator: Lesley A Stevens, MS MD Tufts Medical Center

Publications of Results:
Other Publications:
Responsible Party: Tufts Medical Center Identifier: NCT00905151     History of Changes
Other Study ID Numbers: IRB # 8761
First Posted: May 20, 2009    Key Record Dates
Results First Posted: February 6, 2017
Last Update Posted: March 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: N/A, this study was not funded by the NIH

Keywords provided by Tufts Medical Center:
HIV positive
Kidney disease
Antiretroviral Therapy

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases