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

NCT06717581 | Recruiting

• 1 other identifier: BICTER
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HIV; Drug Interactions; Retrovirus; Comorbidities

Outcome Measures

Primary Outcomes (2)

• Evaluation of the change in the total number of clinically significant drug-drug interactions (DDIs)

  Evaluation of the change in the total number of clinically significant drug-drug interactions (DDIs) between antiretroviral drugs and concomitant drugs following therapeutic switch to bictegravir/emtricitabine/tenofovir alafenamide.

  12 Months

• Evaluation of the change in the number of clinically significant DDIs between antiretroviral drugs and drugs of specific therapeutic classes

  Evaluation of the change in the number of clinically significant DDIs between antiretroviral drugs and drugs of specific therapeutic classes (cardiovascular, hypolipidemic, hypoglycemic, neurological/psychiatric, etc.) following therapeutic switch to bictegravir/emtricitabine/tenofovir alafenamide

  12 Months

Secondary Outcomes (1)

• Evaluation of viro-immunological parameters and incidence of clinical adverse events and treatment discontinuations

  12 Months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study involves the enrollment of 50 patients (number calculated on the basis of the patient's medical history with the main characteristics for the purpose of enrollment in the clinical trial) who will be seen at the outpatient clinics of the Infectious Diseases Operative Unit of the IRCCS, Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola, during the period from January 1, 2021 to December 31, 2022.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Gilead Sciences: collaborator

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 24184475 BACKGROUND

• 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.

  PMID: 23507812 BACKGROUND

• 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.

  PMID: 23349927 BACKGROUND

• 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.

  PMID: 24643444 BACKGROUND

• 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.

  PMID: 26143246 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Cardiovascular Diseases; Metabolic Diseases; Kidney Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Nutritional and Metabolic Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Leonardo Calza, Medicine

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo Calza, Medicine

CONTACT

+390512143353; leonardo.calza@unibo.it

Silvia Cretella, Biology

CONTACT

+390512142865; silvia.cretella@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 5, 2024
• Study Start: October 11, 2024
• Primary Completion: April 11, 2025
• Study Completion: October 11, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR, ANALYTIC CODE
• Time Frame: 12 Months
• Access Criteria: Any formal submission or publication of data derived from this study should be understood as a publication by the Investigator.

Locations

IT (1)