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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Start Date
May 17, 2024
Primary Completion Date
May 1, 2025
Completion Date
May 1, 2025
Last Updated
January 28, 2025
15
ESTIMATED participants
Lead Sponsor
University of Manchester
NCT06694805
NCT04142047
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07428330