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NCT Number: NCT07692295

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

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.

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Key information

Conditions

HIV

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Baseline demographic and categorical clinical characteristics of PTC and PIC (sex, ART regimen type, early ART initiation) will be summarized as proportions. Continuous variables (age [years], ART duration [years], plasma HIV-1 RNA [copies/mL], leukocyte counts [cells/µL], biochemical parameters) will be summarized separately using descriptive statistics.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 1.Documented refusal of data use for research

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention (observational cohort)

Primary outcomes

  1. Intact proviral HIV DNA reservoir size in PTC and PIC before and during ATI

    Time frame: 1 year

    Reservoir size will be measured as intact proviral HIV DNA and reported as log copies per 10^6 CD4+ cells. Reservoir size in PTC, PIC, and NC before and after ATI will be described according to data distribution.

  2. Total integrated HIV DNA reservoir size in PTC and PIC before and during ATI

    Time frame: 1 year

    Reservoir size will be measured as total integrated HIV DNA and reported as log copies per 10^6 PBMC. Reservoir size in PTC, PIC, and NC before and after ATI will be described according to data distribution.

  3. Inducible HIV reservoir size in PTC and PIC before and during ATI

    Time frame: 1 year

    Reservoir size will be measured as inducible HIV and reported as log HIV RNA or HIV DNA copies. Reservoir size in PTC, PIC, and NC before and after ATI will be described according to data distribution.

  4. Time from the start of ATI until first measurement of HIV RNA >50 copies/mL in PTC and PIC.

    Time frame: 1 year

    A survival analysis will be done for all PTC, PIC and NC who have been sourced from ATI trials. Baseline will be set as the start of the treatment interruption. Time will be noted in weeks until first measurement of HIV-RNA >50 copies/mL for all study participants. Levels correspond to elite controller definition (Deeks & Walker, 2007), PTC definition, and level below which HIV onward transmission rarely occurs (Gray et al., 2001). Analysis is by Kaplan Meier and Cox Proportional Hazard models with loss of viral control as event. Independent variables can be timing of ART initiation, duration of ART, HIV cure intervention (if any), demographic parameters (sex, age, place of birth, country of residence), viral dynamics (subtype, reservoir size) and immune characteristics (cd4+ count, cd8+ count, cd4/cd8 ratio).

  5. Time from the start of ATI until first measurement of HIV RNA >400 copies/mL in PTC and PIC.

    Time frame: 1 year

    A survival analysis will be done for all PTC, PIC and NC who have been sourced from ATI trials. Baseline will be set as the start of the treatment interruption. Time will be noted in weeks until first measurement of HIV-RNA >400 copies/mL for all study participants. Levels correspond to elite controller definition (Deeks & Walker, 2007), PTC definition, and level below which HIV onward transmission rarely occurs (Gray et al., 2001). Analysis is by Kaplan Meier and Cox Proportional Hazard models with loss of viral control as event. Independent variables can be timing of ART initiation, duration of ART, HIV cure intervention (if any), demographic parameters (sex, age, place of birth, country of residence), viral dynamics (subtype, reservoir size) and immune characteristics (cd4+ count, cd8+ count, cd4/cd8 ratio).

  6. Time from the start of ATI until first measurement of HIV RNA > 1000 copies/mL in PTC and PIC.

    Time frame: 1 year

    A survival analysis will be done for all PTC, PIC and NC who have been sourced from ATI trials. Baseline will be set as the start of the treatment interruption. Time will be noted in weeks until first measurement of HIV-RNA >1000 copies/mL for all study participants. Levels correspond to elite controller definition (Deeks & Walker, 2007), PTC definition, and level below which HIV onward transmission rarely occurs (Gray et al., 2001). Analysis is by Kaplan Meier and Cox Proportional Hazard models with loss of viral control as event. Independent variables can be timing of ART initiation, duration of ART, HIV cure intervention (if any), demographic parameters (sex, age, place of birth, country of residence), viral dynamics (subtype, reservoir size) and immune characteristics (cd4+ count, cd8+ count, cd4/cd8 ratio).

  7. Number and severity of adverse events during and after ATI.

    Time frame: 1 year

    Medical events in PTC, PIC and NC recorded in the clinical file will be described using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. If medical events have been reported using varied terminology in the ATI trials, two separate evaluators will reclassify them using CTCAE v5.0 terminology. In instances of conflicting classifications, an impartial researcher will make the final determination.

  8. Biobank with samples from PTC, PIC and NC including sampling time points and material available.

    Time frame: 1 year from screening

    Available samples will be indexed from previously performed ATI trials. An inventory will be made of the number of samples, type, volume, time of sampling, sampling technique and storage medium.

Study contacts

Contact information is provided by the study sponsor or research team.

Casper Rokx

CONTACT

[email protected]

+31618069137

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Centre Hospitalier Universitaire Vaudois
  • Charite University, Berlin, Germany
  • Chelsea and Westminster NHS Foundation Trust
  • EU2Cure consortium
  • European Aids Treatment Group (EATG), Brussels, Belgium
  • Fundació Lluita contra les Infeccions
  • Guy's and St Thomas' NHS Foundation Trust
  • Hospital Universitari Vall d'Hebron Research Institute
  • IRCCS San Raffaele
  • Imperial College London
  • Institut Pasteur
  • IrsiCaixa
  • Medical University of Warsaw
  • Oslo University Hospital
  • Pomeranian Medical University Szczecin
  • Radboud University Medical Center
  • University Ghent
  • University Hospital, Ghent
  • University of Aarhus
  • University of Oxford

Registry information

Official study title

Biomarkers for Post-treatment Control in HIV: International Multicenter Study of the EU2Cure Research Consortium (EU2Control)

Acronym: EU2Control

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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