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

NCT ID: NCT06100211

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2025-05-31

Brief Summary

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.

Conditions

HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ART switch group

These are individuals who complete a planned switch of ART regimen from one class of drugs or delivery method to another.

No interventions assigned to this group

Control group

This group continue on their stable ART regimen.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manchester

OTHER

Sponsor Role: lead

Responsible Party

Gabriella Lindergard

Clinical Lecturer in Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Gabriella LA Lindergard, PhD

Role: CONTACT

gabriella.lindergard@manchester.ac.uk

+447855212958

Facility Contacts

Elizabeth Mainwaring

Role: primary

R&D.applications@mft.nhs.uk

+44 161 276 3340

Other Identifiers

333914

Identifier Type: -

Identifier Source: org_study_id