Fact CheckerSign in

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

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Saint-Pierre Hospital
Coordinator of this site? Confirm its status
BrusselsBelgiumUnknown status
Faculty Hospital Bulovka
Coordinator of this site? Confirm its status
PragueCzechiaUnknown status
University Hospital Bonn, Klinisches StudieZentrum Immun.
Coordinator of this site? Confirm its status
BonnGermanyUnknown status
University Hospital Cologne
Coordinator of this site? Confirm its status
CologneGermanyUnknown status
University Clinic Hamburg Eppendorf
Coordinator of this site? Confirm its status
EppendorfGermanyUnknown status
J.W.Goethe University Hospital
Coordinator of this site? Confirm its status
Frankfurt am MainGermanyUnknown status
ICH Study Center, Innere Medizin
Coordinator of this site? Confirm its status
HamburgGermanyUnknown status
Aarhus University Hospital
Coordinator of this site? Confirm its status
AarhusDenmarkUnknown status
Rigshospitalet
Coordinator of this site? Confirm its status
CopenhagenDenmarkUnknown status
Hvidovre Universitets Hospital
Coordinator of this site? Confirm its status
HvidovreDenmarkUnknown status
Odense Universitetshospital
Coordinator of this site? Confirm its status
OdenseDenmarkUnknown status
Hosp. Universitari Germans Trias i Pujol, Hospital de dia VIH
Coordinator of this site? Confirm its status
BadalonaSpainUnknown status
Hospital de la Santa Creu i Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Royal Sussex County Hospital, HIV/GUM Research
Coordinator of this site? Confirm its status
BrightonUnited KingdomUnknown status
Western General Hospital
Coordinator of this site? Confirm its status
EdinburghUnited KingdomUnknown status
University College London, Mortimer Market Centre
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Imperial College
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
University Hospital of Infectious Diseases
Coordinator of this site? Confirm its status
ZagrebCroatiaUnknown status
Hadassah Hospital
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
Ospedale San Paulo
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Centre hospitalier de Luxembourg
Coordinator of this site? Confirm its status
LuxembourgLuxembourgUnknown status
Wojewodzki Szpital Specjalistyczny im. WI. Bieganskiego
Coordinator of this site? Confirm its status
LodzPolandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.