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

NCT06717581 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-12-05

No results posted yet for this 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.

Conditions

  • HIV Infections
  • Drug Interaction
  • Elderly Infection
  • Comorbidities and Coexisting Conditions
  • Cardiovascular Diseases
  • Metabolic Disease
  • Renal Disease
  • Osteoporosis Risk
  • Neoplasms

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Leonardo Calza, Medicine · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-11
Primary Completion
2025-04-11
Completion
2025-10-11

Countries

  • Italy

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06717581 on ClinicalTrials.gov