Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older.
Condition(s) studied
Study 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.
Eligibility
Primary outcome measure(s)
- Evaluation of the change in the total number of clinically significant drug-drug interactions (DDIs) — 12 Months
Evaluation of the change in the total number of clinically significant drug-drug interactions (DDIs) between antiretroviral drugs and concomitant drugs following therapeutic switch to bictegravir/emtricitabine/tenofovir alafenamide. - Evaluation of the change in the number of clinically significant DDIs between antiretroviral drugs and drugs of specific therapeutic classes — 12 Months
Evaluation of the change in the number of clinically significant DDIs between antiretroviral drugs and drugs of specific therapeutic classes (cardiovascular, hypolipidemic, hypoglycemic, neurological/psychiatric, etc.) following therapeutic switch to bictegravir/emtricitabine/tenofovir alafenamide
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Italy | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06717581 on ClinicalTrials.gov ↗ ← All trials in Italy