Actively Recruiting

Age: 18Years +
All Genders
NCT06717581

Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older.

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-12-05

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

I

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Lead Sponsor

G

Gilead Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

Several cohort studies have recently shown a significant increase in the mean age of PLWH ( People Living With HIV) and in the prevalence of people in advanced age in the various cohorts, as a result of the marked increase in the mean life expectancy of these people achieved by modern antiretroviral combination therapies. However, the high prevalence of comorbidities exposes PLWH in old age to the need to take multiple drug treatments in addition to antiretroviral therapy, with the gradually increasing risk of unfavorable pharmacokinetic interactions between antiretroviral drugs and drugs taken to treat the comorbidities. This project consists of an observational, cohort, retrospective, single-center study and aims to evaluate the variation in the number and type of clinically significant drug interactions between antiretroviral therapy and concomitant therapies in PLWH aged \>60 years on stable antiretroviral therapy who, for any reason at the Clinician's discretion, have made a switch from ongoing antiretroviral therapy to the bictegravir/emtricitabine/tenofovir alafenamide regimen.

CONDITIONS

Official Title

Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 60 years
  • Having non-infectious comorbidities treated with medications
  • Currently receiving bictegravir/emtricitabine/tenofovir alafenamide therapy at enrollment
Not Eligible

You will not qualify if you...

  • Evidence of viral resistance to integrase inhibitors, emtricitabine, or tenofovir based on genotypic resistance testing
  • Presence of severe acute infectious disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

L

Leonardo Calza, Medicine

CONTACT

S

Silvia Cretella, Biology

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older. | DecenTrialz