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

Study Overview
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Brief Summary
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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. 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). We know 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 we 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 two months after the switch. We hope that if we can understand the effects different classes and delivery methods of antiretroviral have on an individual's gut microbiome, we can take this 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.

Official Title
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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.

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥18 years. Willing to undergo stool sample collection on two occasions. Able to give written, informed consent. Have evidence of HIV infection Have been on stable antiretroviral treatment for the previous ≥12months. Planning to switch ART regimen from one class of drugs or delivery method to another. Exclusion Criteria: HIV viral load >50 copies/ml blood

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ART switch group<br>These are individuals who complete a planned switch of ART regimen from one class of drugs or delivery method to another. | |
| Control group<br>This group continue on their stable ART regimen. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure changes in diversity and abundance of bacterial species in stool sample collected before and after a change of ART. |  | 4-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To link level of bacterial diversity with different ART regiments. |  | 4-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, gut microbiome, antiretroviral treatment