Tenofovir Pharmacology in Older HIV Infected Individuals

NCT02304263 | Completed

• 2 other identifiers: 14-1297UL1TR001082
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Tenofovir continues to play a vital role in the treatment of the human immunodeficiency virus (HIV) and as the age of the HIV-infected population increases in the United States and worldwide, there is an urgent need to understand the extent to which older age influences the way this antiretroviral medication works in the body. The investigators study aims to characterize and compare the pharmacology of tenofovir in older versus younger HIV-infected adults and to assess kidney function over the course of approximately one year. The investigators will be analyzing tenofovir levels in different compartments of the blood and in hair samples, and will be assessing the relationship between tenofovir concentrations and changes in kidney function over time in the older and younger cohorts. Lastly, the investigators will be evaluating the relationship between tenofovir concentrations and functional status (including body composition, bone mineral density, and frailty) in study participants.

Conditions

HIV; Aging

Keywords

tenofovir; aging; renal function; HIV; frailty

Outcome Measures

Primary Outcomes (4)

• iGFR values and pharmacokinetic parameters of TFV in plasma, RBC, DBS, peripheral blood mononuclear cells (PBMC), and scalp hair in older versus younger adults

  1 year

• iGFR change over a one year time period in older versus younger adults

  1 year

• Bone mineral density DXA score changes for hip and lumbar vertebrae over a one year time period in older versus younger adults

  1 year

• Relationship between TFV pharmacology, iGFR,and frailty score in older versus younger adults

  1 year

Secondary Outcomes (7)

• Clinical and laboratory predictors of iGFR and TFV levels in blood and hair, including genetic predictors in those who consent, in older versus younger adults

  1 year

• Pharmacological measures of cumulative drug exposure in relation to traditional measures of drug adherence in older versus younger adults (Compare DBS and hair drug levels to pharmacy refill data and self-report (using visual analog scale).)

  1 year

• Estimated GFR (using Cockgroft-Gault, MDRD, and CKD-Epi) values versus iGFR values in older versus younger adults

  1 year

• Amount of muscle and fat mass (determined by DXA body composition scan) in older versus younger adults

  1 year

• Pharmacokinetic parameters, including steady-state concentrations, of antiretroviral drugs other than tenofovir in older versus younger adults

  1 year

Study Arms (2)

Younger (18-35 years old)

iohexol

Drug: iohexol

Older (>60 years old)

iohexol

Drug: iohexol

Interventions

iohexol DRUG

5mL bolus of 300 mg/ml iohexol (Omnipaque) over 2 minutes

Also known as: Omnipaque

Older (>60 years old); Younger (18-35 years old)

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

Group 1 participants will include 22 adults between the ages of 18-35 years and Group 2 will include 22 individuals \>60 years old.

You may qualify if:

• Participants must be between either 18-30 years or \>60 years of age
• Participants must be HIV-positive and receive care from the Infectious Disease (IDGP) Clinic at the University of Colorado Hospital
• Participants must have a history of consistent antiretroviral therapy with a qualifying regimen that includes TFV for at least one year
• Participants must have a suppressed HIV-RNA load (\<48 copies/mL on consecutive visits) while on a TFV-based regimen

You may not qualify if:

• eGFR \< 50 ml/min/1.73 m2
• Use of concomitant nephrotoxic agents (aminoglycosides, amphotericin, cyclosporine, etc.)
• Allergy to iodine and/or iohexol
• Uncontrolled, un-medicated hyperthyroidism
• Plans to relocate out of state in the next year
• Currently pregnant or plans to become pregnant in the next year, currently breastfeeding
• Weight ≥ 300 lbs
• Bilateral hip replacements, bilateral hip pins or screws, metallic rods or spinal fusion devices in the lumbar spine
• Any medical, social, or mental-health issue(s) that, in the opinion of the investigators, could interfere with the study outcomes

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of California, San Francisco: collaborator

MeSH Terms

Conditions

Frailty

Interventions

Iohexol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Sharon M Seifert, PharmD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: December 1, 2014
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 26, 2016

Record last verified: 2016-09