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NCT06717581Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 5 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
1 Dec 2024
Start date
11 Oct 2024
Primary completion date
11 Apr 2025
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Diseases
HIV, Osteoporosis
NCT number
NCT06717581

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From 11 Oct 2024 to the primary completion date, 11 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Genotypic resistance testing that present or past evidence of viral resistance to the integrase inhibitor class, to emtricitabine or to tenofovir

Other illness

  • Severe acute infectious disease

Who the study is looking for

  • Age \> 60 years
  • Non-infectious comorbidities receiving drug therapy
  • Receiving BIC/TAF/FTC therapy at the time of of enrollment

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Coordinator of this site? Confirm its status
BolognaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.