HIV and Kidney Function Study

NCT00905151 | Completed Results

• 1 other identifier: IRB # 8761
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infections; AIDS

Keywords

HIV positive; AIDS; antiretroviral; Kidney disease; Antiretroviral Therapy

Outcome Measures

Primary Outcomes (1)

• Performance of Glomerular Filtration Rate (GFR) Estimating Equations

  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.

  Blood samples for plasma iohexol clearance were taken at approximately 10, 30, 120, and 240 minutes post-iohexol dose.

Study Arms (1)

HIV Positive

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from hospital based practices as well as from the community.

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

Sponsors & Collaborators

• Tufts Medical Center: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• University of Alabama at Birmingham: collaborator
• University of Minnesota: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (2)

• Okparavero AA, Tighiouart H, Krishnasami Z, Wyatt CM, Graham H, Hellinger J, Inker LA. Use of glomerular filtration rate estimating equations for drug dosing in HIV-positive patients. Antivir Ther. 2013;18(6):793-802. doi: 10.3851/IMP2676. Epub 2013 Aug 20.

  PMID: 23963249 BACKGROUND

• Inker LA, Wyatt C, Creamer R, Hellinger J, Hotta M, Leppo M, Levey AS, Okparavero A, Graham H, Savage K, Schmid CH, Tighiouart H, Wallach F, Krishnasami Z. Performance of creatinine and cystatin C GFR estimating equations in an HIV-positive population on antiretrovirals. J Acquir Immune Defic Syndr. 2012 Nov 1;61(3):302-9. doi: 10.1097/QAI.0b013e31826a6c4f.

  PMID: 22842844 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole and urine will be retained for future testing.

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; HIV Seropositivity; Kidney Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases

Results Point of Contact

• Title: Associate Professor
• Organization: Tufts Medical Center

linker@tuftsmedicalcenter.org

617-636-2569

Study Officials

• Lesley A Stevens, MS MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 20, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 15, 2017
• Results First Posted: February 6, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)