Clinical Trial

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

Recruiting
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Record status
This record was last updated December 5, 2024 (before its estimated April 11, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT06717581
Lead Sponsor IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators: Gilead Sciences
Conditions HIV Infections, Drug Interaction, Elderly Infection, Comorbidities and Coexisting Conditions, Cardiovascular Diseases, Metabolic Disease, Renal Disease, Osteoporosis Risk +1 more
Enrollment 50 participants
Start Date 2024-10-11
Primary Completion 2025-04-11 (estimated)
Study Completion 2025-10-11 (estimated)
Updated on ClinicalTrials.gov 2024-12-05