HIV InfectionsNCT06717581
Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older.
An observational study of HIV Infections and Drug Interaction, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Drug Interaction, Elderly Infection
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 11 Oct 2024to 11 Oct 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 60 years
- Non-infectious comorbidities receiving drug therapy
- Receiving BIC/TAF/FTC therapy at the time of of enrollment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Leonardo Calza, Medicine, +390512143353, leonardo.calza@unibo.it
Silvia Cretella, Biology, +390512142865, silvia.cretella@aosp.bo.it
About this study
Official title: 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
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.
Read the detailed description
The introduction of integrase inhibitors into clinical practice has greatly improved the efficacy and tolerability of modern antiretroviral combination therapies for the treatment of patients with HIV-1 infection. Indeed, these drugs have shown in registration studies high antiviral potency associated with a negligible incidence of short- and long-term adverse events, so much so that they are consistently included in the drug regimens recommended by all international guidelines for the treatment of HIV-positive patients naive to antiretroviral therapy.
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
- HIV Infections, Drug Interaction, Elderly Infection, Comorbidities and Coexisting Conditions, Cardiovascular Diseases, Metabolic Disease
- Keywords
- HIV, Drug Interactions, Retrovirus, Comorbidities
- Medical subject headings
- HIV Infections, Cardiovascular Diseases, Metabolic Diseases, Kidney Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 Months
Secondary outcomes (1)
Evaluation of viro-immunological parameters and incidence of clinical adverse events and treatment discontinuations
Evaluation of viro-immunological parameters and incidence of clinical adverse events and treatment discontinuations during the follow-up period.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start11 Oct 2024
- Primary completion11 Apr 2025 (estimated)
- Study completion11 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Leonardo Calza, Medicine, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717581
- Sponsor's protocol ID
- BICTER
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: The investigator agrees to make the results public at the end of the study. For this purpose, the study will be registered on an Open Science platform. Any formal submission or publication of data derived from this study should be understood as a publication by the Investigator.
Publications
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.
PubMed 24184475Pompili 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.
PubMed 23507812Parruti 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.
PubMed 23349927Leyro 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.
PubMed 24643444McIntosh 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.
PubMed 26143246