NCT06717581 Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older.
| NCT ID | NCT06717581 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | HIV Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-10-11 |
| Primary Completion | 2025-04-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-10-11 with a primary completion date of 2025-04-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Leonardo Calza, Medicine
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06717581 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06717581 currently recruiting?
Yes, NCT06717581 is actively recruiting participants. Contact the research team at leonardo.calza@unibo.it for enrollment information.
Where is the NCT06717581 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06717581 clinical trial?
NCT06717581 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Leonardo Calza, Medicine at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 50 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.