Biomarkers for Post-treatment Control in HIV: International Study of the EU2Cure Research Consortium (Phase I)

ConditionHIV
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorErasmus Medical Center

About this trial

Antiretroviral therapy (ART) has transformed HIV from a deadly disease into a lifelong infection that can be controlled. Nevertheless, in the majority of people living with HIV (PWH), discontinuation of ART results in viral rebound due to a latent proviral reservoir. Rarely, individuals known as post-treatment controllers (PTC) demonstrate prolonged viral control even after ceasing ART. Investigating the underlying mechanisms driving this sustained viral control has been a goal for the HIV research community. However, previous studies have been hindered by the scarcity of PTC cases, thereby restricting the potential for associative and translational research. Consequently, the aim of this study is to collect and meta-analyse the data from prior trials where PTC have been identified, as well as to retrospectively identify PTC from the routine care outside trials in a multicentre, multinational study called EU2Control. The aggregated clinical data, and the already collected material from trials where PWH consented for use in additional studies on HIV, will be analyzed with the goal to identify predictive biomarkers for sustained viral control. This study will be part of the research line on HIV cure from an ongoing collaborative consortium (EU2Cure). The first phase of this research line involves a retrospective cohort for meta-analysis and establishment of a biobank.

Eligibility criteria

Qualifiers

PTC: Viremic people living with HIV (HIV-RNA >1000c/mL) before ART initiation. Plasma HIV-RNA off ART ≤400c/mL at least 2 times at ≥24weeks apart and at ≥2/3rds of HIV-RNA measurements. Elite PTC with ≤50c/mL will be identified.

Post intervention controller (PIC): People living with HIV from ATI or MAP studies who meet the PTC criteria as per ATI/MAP study defined. Additional stratification occurs according to the duration of and level of suppressed plasma HIV-RNA (e.g. ≤400c/mL off ART at least 2 times for ≥8 weeks apart). This is done to streamline PIC definitions and capture PIC inMAP studies with an ART pause of less than 24 weeks.

Controls: non-controllers (NC) with plasma HIV-RNA >1000 c/mL after ART interruption.

Suppressors: viremic people living with HIV (HIV-RNA >1000c/mL) before ART initiation who became HIV-RNA <50c/mL suppressed on ART, remained on ART, and never had viral rebound.

Disqualifiers

1.Documented refusal of data use for research

Trial design

Treatments tested in this trial

  • No Intervention: Observational Cohort

Treatment groups

200 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Erasmus Medical Center

Lead sponsor

EU2Cure consortium

Collaborator

Radboud University Medical Center

Collaborator

European Aids Treatment Group (EATG), Brussels, Belgium

Collaborator

University Hospital, Ghent

Collaborator

University Ghent

Collaborator

Oslo University Hospital

Collaborator

Charite University, Berlin, Germany

Collaborator

Institut Pasteur

Collaborator

University of Aarhus

Collaborator

IrsiCaixa

Collaborator

Fundació Lluita contra les Infeccions

Collaborator

IRCCS San Raffaele

Collaborator

Imperial College London

Collaborator

University of Oxford

Collaborator

Guy's and St Thomas' NHS Foundation Trust

Collaborator

Chelsea and Westminster Hospital, UK

Collaborator

Pomeranian Medical University Szczecin

Collaborator

Hospital Universitari Vall d'Hebron Research Institute

Collaborator

Medical University of Warsaw

Collaborator

Centre Hospitalier Universitaire Vaudois

Collaborator