An observational study in HIV Infections, sponsored by University of Manchester. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by University of Manchester · Observational
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.
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 15 is below the median of 200 across 731 observational studies indexed under HIV Infections.
Browse HIV Infections studies →University of Manchester is the lead sponsor of 201 studies on the registry; 45 are open to participants now.
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HIV infected individuals on stable antiretroviral treatment.
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Exclusion Criteria:
These are individuals who complete a planned switch of ART regimen from one class of drugs or delivery method to another.
This group continue on their stable ART regimen.
To measure changes in diversity and abundance of bacterial species in stool sample collected before and after a change of ART.
The number of different bacterial species and the abundance of these species will be measured by shallow shotgun sequencing before and after the change in antiretroviral treatment.
Time frame: 3-8 weeks
To link level of bacterial diversity with different ART regiments.
To measure the level of change in the number and the abundance of bacterial species after a change of antiretroviral treatment.
Time frame: 3-8 weeks
Plan to share: No
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