Clinical trial Recruiting at 1 site Observational Ages 18 and up

Understanding how HIV treatment affects gut bacteria

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.

Run by University of Manchester · NCT06100211 · Data updated 2026-11-12

This study is trying to see how different HIV treatments affect gut bacteria in people living with HIV by looking at their stool samples before and after they change medications.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment15 (estimated)
SponsorUniversity of Manchester
Academic / other
Locations1 site (Manchester, Greater Manchester)
StatusRecruiting
StartedMay 17, 2024
Main results expectedMay 2025
Study endsMay 2025
Registry record updatedJanuary 28, 2025
Trial IDNCT06100211 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with HIV who have been on stable antiretroviral treatment for at least 12 months and are planning to switch their ART regimen.

Probably not a fit

Patients with a viral load greater than 50 copies/ml blood may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the impact of antiretroviral therapy (ART) on the gut microbiome in individuals with HIV. By collecting stool samples from participants before and after switching their ART regimen, researchers hope to gain insights into how different antiretroviral drugs influence gut health. The findings could lead to more personalized treatment options based on individual gut microbiome profiles. This research is crucial as gut health is linked to overall well-being and can affect various health conditions.

Why it matters

Potential benefit: If successful, this study could lead to more tailored HIV treatments that improve gut health and overall patient outcomes.

How similar studies have gone: While there has been growing interest in the relationship between HIV and the gut microbiome, this specific approach to studying the effects of ART on gut health is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Manchester University NHS Foundation Trust
    Manchester, Greater Manchester, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.