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Clinical Trials in Italy / NCT05421286
Active, not recruiting Observational

The MISTRAL Study: Gut Microbiome Correlates of Serious AIDS and Non-AIDS Events

NCT05421286 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2022-09-28
Last updated
2025-04-11

Condition(s) studied

HIV-1-infectionInflammationAIDS

Study summary

MISTRAL (Microbiome-based stratification of individuals at risk of HIV-1 acquisition, chronic clinical complications, antimicrobial drug resistance, and unresponsiveness to therapeutic HIV-1 vaccination) is a 5-year EU Horizon 2020 project, running from 1/1/2020 - 31/12/2025.

The project is led by Fundacio Privada Institut de Recerca de la Sida-Caixa CAIXA in Barcelona and aims to explore the gut microbiota in relation to HIV-1, seeking microbiome biomarkers to support development of interventions that mitigate infection and enhance response to vaccines and therapies.

If successful, MISTRAL will benefit millions of human beings living with, or at risk of acquiring HIV-1 infection, and will produce novel concepts and technical innovations applicable to other human diseases. By doing that, MISTRAL will help to unlock the full clinical potential of the human microbiome to stratify patient outcomes and will irreversibly bring microbiome science closer to clinical practice

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * HIV-1 positive persons * Age ≥50 years old * Prospectively followed in a EuroSIDA site Exclusion Criteria: * Creatine Clearance \<50 * Child-Pugh C end-stage liver disease * Any ongoing severe life-threatening disease * Experiencing any of the following events prior to inclusion: myocardial infarction, stroke, an invasive cardiovascular procedure, AIDS-defining infections (diagnosed with 5 years of MISTRAL enrolment), and prior AIDS cancer on non-AIDS cancers (excluding non-melanoma skin cancers)

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
CHU Saint-Pierre Hospital Brussels Belgium
University Hospital of Infectious Diseases Zagreb Croatia
Faculty Hospital Bulovka Prague Czechia
Aarhus University Hospital Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Hvidovre Universitets Hospital Hvidovre Denmark
Odense Universitetshospital Odense Denmark
University Hospital Bonn, Klinisches StudieZentrum Immun. Bonn Germany
University Hospital Cologne Cologne Germany
University Clinic Hamburg Eppendorf Eppendorf Germany
J.W.Goethe University Hospital Frankfurt am Main Germany
ICH Study Center, Innere Medizin Hamburg Germany
Hadassah Hospital Jerusalem Israel
Ospedale San Paulo Milan Italy
Centre Hospitalier de Luxembourg Luxembourg Luxembourg
Wojewodzki Szpital Specjalistyczny im. WI. Bieganskiego Lodz Poland
Hosp. Universitari Germans Trias i Pujol, Hospital de dia VIH Badalona Spain
Hospital de la Santa Creu i Sant Pau Barcelona Spain
Royal Sussex County Hospital, HIV/GUM Research Brighton United Kingdom
Western General Hospital Edinburgh United Kingdom
Imperial College London United Kingdom
University College London, Mortimer Market Centre London United Kingdom

More Rigshospitalet, Denmark trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05421286 on ClinicalTrials.gov ↗ ← All trials in Italy