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HIV and Kidney Function Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Mount Sinai School of Medicine
University of Alabama at Birmingham
University of Minnesota - Clinical and Translational Science Institute
Gilead Sciences
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00905151
First received: May 15, 2009
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

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
HIV Infections
AIDS

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Evaluation of the Performance of GFR Estimating Equations in HIV Positive Patients

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • The primary outcome is the performance of GFR estimating equations [ Time Frame: Endpoints are not applicable. Outcomes are determined based on laboratory assay results ] [ Designated as safety issue: No ]

Biospecimen Description:

Whole and urine will be retained for future testing.


Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: October 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV Positive
Across-sectional analysis of 200 HIV+ patients with varying levels of kidney function

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905151

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

No publications provided

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00905151     History of Changes
Other Study ID Numbers: IRB # 8761
Study First Received: May 15, 2009
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on March 10, 2013