Understanding how HIV treatment affects gut bacteria
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.
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 type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manchester Academic / other |
| Locations | 1 site (Manchester, Greater Manchester) |
| Trial ID | NCT06100211 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with a viral load greater than 50 copies/ml blood may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Manchester, Greater Manchester
- Manchester University NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Gabriella LA Lindergard, PhD
- Email: gabriella.lindergard@manchester.ac.uk
- Phone: +447855212958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.