HIV and the gut microbiome

  • Research type

    Research Study

  • Full title

    A prospective observational study of the impact on the gut microbiome in HIV-infected individuals in Manchester, UK, when switching from one class of antiretroviral drugs or delivery method to another class or delivery method.

  • IRAS ID

    333914

  • Contact name

    Gabriella Lindergard

  • Contact email

    Gabriella.Lindergard@manchester.ac.uk

  • Sponsor organisation

    University of Manchester

  • Clinicaltrials.gov Identifier

    NCT06100211

  • Duration of Study in the UK

    0 years, 11 months, 31 days

  • Research summary

    This is a study that aims to contribute to our understanding of how antiretroviral therapy effects the gut microbiome which, if known, could inform decisions about drug choices at an individual level.
    Our gut health is extremely important for all aspects of our wellbeing both at the level of our body and our brain. There are big differences in the gut microbiome composition seen in people with untreated HIV infection compared with non-infected individuals. This disrupted balance does however, not seem to be restored when starting on antiretroviral therapy and different classes of antiretrovirals may have different effects. We would therefore like to compare the gut flora of HIV infected individuals before and after a planned switch from one class of antiretroviral treatment to another or switch of delivery method of that drug, with the bacterial gut microbiome 3-8 weeks after the switch.
    People living with HIV and having their care at North Manchester General Hospital will be approached about the study if they have been identified by their direct care team as planning for a switch in their drug regimen. Individuals who choose to enrol in the study will be asked to supply a blood sample and a stool sample before the drug switch and then again, 3-8 weeks after the switch. On both of these occasions they will also be asked a few questions around their medical history, eating habits and the level of exercise they are engaged in. Their time in the study would be max 8 weeks but they will be asked if they would want to be contact again in the future when the result of the study becomes available.

  • REC name

    North West - Greater Manchester South Research Ethics Committee

  • REC reference

    24/NW/0009

  • Date of REC Opinion

    5 Feb 2024

  • REC opinion

    Further Information Favourable Opinion