Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Rigshospitalet, Denmark

Collaborating Sponsors:

IrsiCaixa

Horizon 2020 - European Commission

Conditions:

HIV-1-infection

Inflammation

Eligibility:

All Genders

50+ years

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 vaccinati...

Detailed Description

Background and Rationale: The HIV/AIDS pandemic continues to be one of the major health challenges ever faced by mankind. Far from being resolved, HIV is soaring in Eastern Europe (60% increase in new...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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)

Key Trial Info

Start Date :

September 28 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2025

Estimated Enrollment :

991 Patients enrolled

Trial Details

Trial ID

NCT05421286

Start Date

September 28 2022

End Date

December 1 2025

Last Update

April 11 2025

Active Locations (22)

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Page 1 of 6 (22 locations)

1

CHU Saint-Pierre Hospital

Brussels, Belgium, 1000

2

University Hospital of Infectious Diseases

Zagreb, Croatia

3

Faculty Hospital Bulovka

Prague, Czechia

4

Aarhus University Hospital

Aarhus, Denmark, 8200