Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06100211
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-10-20
Brief Title:
HIV and Changes in the Gut Microbiome After Changes in Antiretroviral Therapy ART
Sponsor:
University of Manchester
Organization:
University of Manchester
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 individuals 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
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 individuals 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None