Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older.
NCT ID: NCT06717581
Last Updated: 2024-12-05
Study Results
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Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-10-11
2025-10-11
Brief Summary
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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.
Detailed Description
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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.
PLWH in advanced age, however, have a high prevalence of noninfectious comorbidities (cardiovascular disease, metabolic abnormalities, chronic renal failure, osteopenia-osteoporosis, neoplastic diseases, etc.), brought about by age-related aging but also by their accelerated biological aging caused by HIV infection and associated chronic inflammation and immunoactivation.
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.
The effect of such interactions can be either a reduction in plasma concentrations with reduced efficacy of antiretroviral drugs or an increase in plasma levels of concomitant drugs and the risk of toxicity induced by them.
The availability of integrase inbitors such as bictegravir, i.e., antiretroviral drugs characterized by a very low risk of drug interactions (because they are generally not metabolized by hepatic cytochrome P450 3A4 isoenzymes), has made it possible to significantly reduce the risk of interactions between antiretroviral therapy and concomitant therapy, especially in people of advanced age, while providing high viro-immunologic efficacy and a favorable effect on the cardio-metabolic profile.
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
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Non-infectious comorbidities receiving drug therapy
* Receiving BIC/TAF/FTC therapy at the time of of enrollment
Exclusion Criteria
* Severe acute infectious disease
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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Principal Investigators
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Leonardo Calza, Medicine
Role: PRINCIPAL_INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Locations
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, , Italy
Countries
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Central Contacts
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Facility Contacts
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Leonardo Calza, Medicine
Role: primary
Silvia Cretella, Biology
Role: backup
References
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McIntosh RC, Ironson G, Antoni M, Kumar M, Fletcher MA, Schneiderman N. Alexithymia is linked to neurocognitive, psychological, neuroendocrine, and immune dysfunction in persons living with HIV. Brain Behav Immun. 2014 Feb;36:165-75. doi: 10.1016/j.bbi.2013.10.024. Epub 2013 Nov 1.
Pompili M, Pennica A, Serafini G, Battuello M, Innamorati M, Teti E, Girardi N, Amore M, Lamis DA, Aceti A, Girardi P. Depression and affective temperaments are associated with poor health-related quality of life in patients with HIV infection. J Psychiatr Pract. 2013 Mar;19(2):109-17. doi: 10.1097/01.pra.0000428557.56211.cf.
Parruti G, Vadini F, Sozio F, Mazzott E, Ursini T, Polill E, Di Stefano P, Tontodonati M, Verrocchio MC, Fulcheri M, Calella G, Santilli F, Manzoli L. Psychological factors, including alexithymia, in the prediction of cardiovascular risk in HIV infected patients: results of a cohort study. PLoS One. 2013;8(1):e54555. doi: 10.1371/journal.pone.0054555. Epub 2013 Jan 22.
Leyro TM, Vujanovic AA, Bonn-Miller MO. Examining associations between cognitive-affective vulnerability and HIV symptom severity, perceived barriers to treatment adherence, and viral load among HIV-positive adults. Int J Behav Med. 2015 Feb;22(1):139-48. doi: 10.1007/s12529-014-9404-8.
McIntosh RC, Ironson G, Antoni M, Fletcher MA, Schneiderman N. Alexithymia, Assertiveness and Psychosocial Functioning in HIV: Implications for Medication Adherence and Disease Severity. AIDS Behav. 2016 Feb;20(2):325-38. doi: 10.1007/s10461-015-1126-7.
Other Identifiers
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BICTER
Identifier Type: -
Identifier Source: org_study_id