Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older.
Recruiting · NCT06717581 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
View the official record on ClinicalTrials.gov →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.
Who can take part
Inclusion criteria
- Age \> 60 years
- Non-infectious comorbidities receiving drug therapy
- Receiving BIC/TAF/FTC therapy at the time of of enrollment
Exclusion criteria
- Genotypic resistance testing that present or past evidence of viral resistance to the integrase inhibitor class, to emtricitabine or to tenofovir
- Severe acute infectious disease
Where it is running
1 location listed.
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Bologna, Italy