Tenofovir Pharmacology in Older HIV Infected Individuals

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: University of California, San Francisco
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

1. Participants must be between either 18-30 years or >60 years of age

2. Participants must be HIV-positive and receive care from the Infectious Disease (IDGP) Clinic at the University of Colorado Hospital

3. Participants must have a history of consistent antiretroviral therapy with a qualifying regimen that includes TFV for at least one year

4. Participants must have a suppressed HIV-RNA load (<48 copies/mL on consecutive visits) while on a TFV-based regimen

Exclusion Criteria:

1. eGFR < 50 ml/min/1.73 m2

2. Use of concomitant nephrotoxic agents (aminoglycosides, amphotericin, cyclosporine, etc.)

3. Allergy to iodine and/or iohexol

4. Uncontrolled, un-medicated hyperthyroidism

5. Plans to relocate out of state in the next year

6. Currently pregnant or plans to become pregnant in the next year, currently breastfeeding

7. Weight ≥ 300 lbs

8. Bilateral hip replacements, bilateral hip pins or screws, metallic rods or spinal fusion devices in the lumbar spine

9. Any medical, social, or mental-health issue(s) that, in the opinion of the investigators, could interfere with the study outcomes