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

NCT06100211 | Recruiting DMC

• 1 other identifier: 333914
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

HIV; Gut microbiome; Antiretroviral drugs

Outcome Measures

Primary Outcomes (1)

• 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.

  3-8 weeks

Secondary Outcomes (1)

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

  3-8 weeks

Study Arms (2)

ART switch group

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

Control group

This group continue on their stable ART regimen.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV infected individuals on stable antiretroviral treatment.

You may qualify if:

• 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.

You may not qualify if:

• HIV viral load \>50 copies/ml blood

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, stool samples

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Gabriella LA Lindergard, PhD

CONTACT

+447855212958; gabriella.lindergard@manchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer in Nursing

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 25, 2023
• Study Start: May 17, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)