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

NCT05421286 | Active Not Recruiting

• 1 other identifier: The MISTRAL Study
• Study Type: observational
• Target: 991
• Locations: 11 countries
• Sites: 22

Brief 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

Conditions

HIV-1-infection; Inflammation; AIDS

Keywords

HIV-1,; Serious AIDS events; Serious non-AIDS events; Cardiovascular events; Gut microbiome; Infllammation

Outcome Measures

Primary Outcomes (1)

• Incidence of serious AIDS and non-AIDS events

  In particular cardiovascular events, across Europe; and multi-omics (in particular gut microbiome), demographic, dietary, clinical, therapeutic, immunological and viral factors associated with these outcomes

  From date of enrolment until lost to follow-up or death, whichever came first, assessed up to 5 years

Study Arms (1)

PLWH ≥50 years old

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)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participating sites will recruit HIV-1 positive persons age 50 years or older with no prior events who are prospectively followed in a EuroSIDA site

You may qualify if:

• HIV-1 positive persons
• Age ≥50 years old
• Prospectively followed in a EuroSIDA site

You may not qualify if:

• Creatine Clearance \<50
• Child-Pugh C end-stage liver disease
• Any ongoing severe life-threatening disease

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• IrsiCaixa: collaborator
• Horizon 2020 - European Commission: collaborator

Study Sites (22)

CHU Saint-Pierre Hospital

Brussels, 1000, Belgium

Location

University Hospital of Infectious Diseases

Zagreb, Croatia

Location

Faculty Hospital Bulovka

Prague, Czechia

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Hvidovre Universitets Hospital

Hvidovre, Denmark

Location

Odense Universitetshospital

Odense, 5000, Denmark

Location

University Hospital Bonn, Klinisches StudieZentrum Immun.

Bonn, Germany

Location

University Hospital Cologne

Cologne, Germany

Location

University Clinic Hamburg Eppendorf

Eppendorf, Germany

Location

J.W.Goethe University Hospital

Frankfurt am Main, Germany

Location

ICH Study Center, Innere Medizin

Hamburg, Germany

Location

Hadassah Hospital

Jerusalem, Israel

Location

Ospedale San Paulo

Milan, Italy

Location

Centre Hospitalier de Luxembourg

Luxembourg, Luxembourg

Location

Wojewodzki Szpital Specjalistyczny im. WI. Bieganskiego

Lodz, Poland

Location

Hosp. Universitari Germans Trias i Pujol, Hospital de dia VIH

Badalona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Royal Sussex County Hospital, HIV/GUM Research

Brighton, United Kingdom

Location

Western General Hospital

Edinburgh, United Kingdom

Location

Imperial College

London, United Kingdom

Location

University College London, Mortimer Market Centre

London, United Kingdom

Location

Related Publications (3)

• Li SX, Armstrong A, Neff CP, Shaffer M, Lozupone CA, Palmer BE. Complexities of Gut Microbiome Dysbiosis in the Context of HIV Infection and Antiretroviral Therapy. Clin Pharmacol Ther. 2016 Jun;99(6):600-11. doi: 10.1002/cpt.363. Epub 2016 Apr 16.

  PMID: 26940481 BACKGROUND

• Herrera S, Martinez-Sanz J, Serrano-Villar S. HIV, Cancer, and the Microbiota: Common Pathways Influencing Different Diseases. Front Immunol. 2019 Jun 27;10:1466. doi: 10.3389/fimmu.2019.01466. eCollection 2019.

  PMID: 31316514 BACKGROUND

• Hsu DC, Sereti I, Ananworanich J. Serious Non-AIDS events: Immunopathogenesis and interventional strategies. AIDS Res Ther. 2013 Dec 13;10(1):29. doi: 10.1186/1742-6405-10-29.

  PMID: 24330529 BACKGROUND

Related Links

• UNAIDS announces nearly 21 million people living with HIV now on treatment." UNAIDS, 20 Nov. 2017, Press release.
• World Medical Association, 2018
• Journal of the European Union, 2005
• Journal of the European Union, 2016

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, plasma, stool

MeSH Terms

Conditions

Inflammation; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jens Lundgren, Professor

  CHIP, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 16, 2022
• Study Start: September 28, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

BE (1); DK (4); LU (1); PL (1); IT (1); ES (2); CZ (1); DE (5); CR (1); GB (4); IL (1)