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
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