Examining drug interactions in older adults living with HIV
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
This study looks at how different medications interact in older adults with HIV to see if we can improve their treatment plans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06717581 on ClinicalTrials.gov |
What this trial studies
This observational cohort study focuses on individuals aged 60 and older living with HIV who are on stable antiretroviral therapy. It aims to evaluate the variations in clinically significant drug interactions between antiretroviral medications and other treatments for comorbidities commonly found in this age group. The study will analyze data retrospectively from a single center to understand the impact of multiple drug therapies on this population. The findings could help in optimizing treatment regimens for older adults with HIV and their associated health conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged over 60 who are living with HIV and are receiving drug therapy for non-infectious comorbidities.
Not a fit: Patients with evidence of viral resistance to integrase inhibitors or those suffering from severe acute infectious diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of drug interactions, enhancing the safety and efficacy of treatments for older adults living with HIV.
How similar studies have performed: Other studies have indicated the importance of understanding drug interactions in older populations, but this specific focus on older adults with HIV and their unique comorbidities is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Leonardo Calza, Medicine — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Leonardo Calza, Medicine
- Email: leonardo.calza@unibo.it
- Phone: +390512143353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.