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

Sponsor
Erasmus Medical Center
Study ID
NCT07692295
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • No Intervention: Observational Cohort — OTHER
    No intervention (observational cohort)

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
Oct 31, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: PTC
    Viremic PWH (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
  • Arm: Post intervention controller (PIC)
    PWH 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 in MAP studies with an ART pause of less than 24 weeks.
  • Arm: Controls
    non-controllers (NC) with plasma HIV-RNA \>1000 c/mL after ART interruption
  • Arm: Suppressors
    viremic PWH (HIV-RNA \>1000c/mL) before ART initiation who became HIV-RNA \<50c/mL suppressed on ART, remained on ART, and never had viral rebound.

Primary Outcome Measure

Intact proviral HIV DNA reservoir size in PTC and PIC before and during ATI [ Time Frame: 1 year ]

Central Contacts

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