NCT05421286Active, not recruiting
The MISTRAL Study: Gut Microbiome Correlates of Serious AIDS and Non-AIDS Events
Microbiome-based Stratification of Individuals at Risk of HIV-1 Acquisition, Chronic Clinical Complications, Antimicrobial Drug Resistance, and Unresponsiveness to Therapeutic HIV-1 Vaccination
Source: ClinicalTrials.gov · Last updated 11 Apr 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 991 (actual)
- First submitted
- 23 May 2022
- Start date
- 28 Sept 2022
- Primary completion date
- Dec 2025
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- HIV
- NCT number
- NCT05421286
What you commit to
- Study type: Observational
- Participants enrolled: 991
- From 28 Sept 2022 to the primary completion date, Dec 2025
- 22 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Child-Pugh C end-stage liver disease
- Any ongoing severe life-threatening disease
Lab values
- Creatine Clearance \<50
Who the study is looking for
- HIV-1 positive persons
- Age ≥50 years old
- Prospectively followed in a EuroSIDA site
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Saint-Pierre Hospital Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Faculty Hospital Bulovka Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| University Hospital Bonn, Klinisches StudieZentrum Immun. Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| University Hospital Cologne Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| University Clinic Hamburg Eppendorf Coordinator of this site? Confirm its status | Eppendorf | Germany | Unknown status |
| J.W.Goethe University Hospital Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
| ICH Study Center, Innere Medizin Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Hvidovre Universitets Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Unknown status |
| Odense Universitetshospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Hosp. Universitari Germans Trias i Pujol, Hospital de dia VIH Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Royal Sussex County Hospital, HIV/GUM Research Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
| Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| University College London, Mortimer Market Centre Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Imperial College Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University Hospital of Infectious Diseases Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Hadassah Hospital Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Ospedale San Paulo Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Centre hospitalier de Luxembourg Coordinator of this site? Confirm its status | Luxembourg | Luxembourg | Unknown status |
| Wojewodzki Szpital Specjalistyczny im. WI. Bieganskiego Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.