Actively Recruiting

Age: 18Years +
All Genders
NCT06100211

HIV and Changes in the Gut Microbiome After Changes in Antiretroviral Therapy (ART)

Led by University of Manchester · Updated on 2025-01-28

15

Participants Needed

1

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a study that aims to contribute to the understanding of how antiretroviral therapy effects the gut microbiome which, if known, could inform decisions about drug choices at an individual level. The gut health is extremely important for all aspects of a persons wellbeing both at the level of the body and the brain. In recent years there has been much interest and better understanding of the role of the bacteria, viruses and other microorganisms that live in the human gut (the gut microbiome). It is known that disturbing the balance between the different species of bacteria in the gut can have consequences including diarrhoea, inflammatory and autoimmune conditions and has also been linked to obesity. 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 not seem to be restored when starting on antiretroviral therapy. Different classes of antiretrovirals seem to have different effects but this has been hard to establish because studies aiming to look at this has been large population studies where it can be hard to tease out cause and effect. In this study the investigators are instead aiming to compare an individual with themselves by comparing the bacterial gut microbiome before the person switches from one class of antiretroviral treatment to another or switches the delivery method of that drug, with the bacterial gut microbiome 3-8 weeks after the switch. The investigators hope that if this can be understood the effects different classes and delivery methods of antiretroviral have on an individual's gut microbiome, can be taken into account when deciding on the best HIV therapy for a person. In the long term, this would lessen the negative effects of being on a life-long treatment.

CONDITIONS

Official Title

HIV and Changes in the Gut Microbiome After Changes in Antiretroviral Therapy (ART)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Willing to provide stool samples on two occasions
  • Able to give written, informed consent
  • Have evidence of HIV infection
  • On stable antiretroviral treatment for at least 12 months
  • Planning to switch ART regimen from one drug class or delivery method to another
Not Eligible

You will not qualify if you...

  • HIV viral load greater than 50 copies/ml blood

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom, M13 9WL

Actively Recruiting

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Research Team

G

Gabriella LA Lindergard, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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