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NCT Number: NCT06100211

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location status: Recruiting

Location contact

Elizabeth Mainwaring

CONTACT

R&[email protected]

+44 161 276 3340

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To measure changes in diversity and abundance of bacterial species in stool sample collected before and after a change of ART.

    Time frame: 3-8 weeks

    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.

Secondary outcomes

  1. To link level of bacterial diversity with different ART regiments.

    Time frame: 3-8 weeks

    To measure the level of change in the number and the abundance of bacterial species after a change of antiretroviral treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriella LA Lindergard, PhD

CONTACT

[email protected]

+447855212958

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 25, 2023
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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