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Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older on Stable Antiretroviral Therapy Making a Switch to Bictegravir/Tenofovir Alafenamide/Emtricitabine

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 60 years

• Non-infectious comorbidities receiving drug therapy

• Receiving BIC/TAF/FTC therapy at the time of of enrollment

Locations
Other Locations
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Contact Information
Primary
Leonardo Calza, Medicine
leonardo.calza@unibo.it
+390512143353
Backup
Silvia Cretella, Biology
silvia.cretella@aosp.bo.it
+390512142865
Time Frame
Start Date: 2024-10-11
Estimated Completion Date: 2025-10-11
Participants
Target number of participants: 50
Treatments
people with HIV (PLWH) aged 60 years and older
people with HIV (PLWH) aged 60 years and older on stable antiretroviral therapy who switch to bictegravir/tenofovir alafenamide/emtricitabine.
Related Therapeutic Areas
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators: Gilead Sciences

This content was sourced from clinicaltrials.gov

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