HIVEU2ControlNCT07692295
Biomarkers for Post-treatment Control in HIV: International Study of the EU2Cure Research Consortium (Phase I)
An observational study of HIV, run by Erasmus Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: People living with HIV meeting PTC inclusion criteria from previous ATI trials. In addition, PTC from routine care will be identified and included. Non controllers will be identified from ATI trials and routine care. To analyse the reservoir size, PTC (both from routine care and ATI trials) will be matched in a 1:1 ratio with non-controllers (NC). We will also match NC to a control group of people living with HIV who did not undergo an ATI (Suppressors). Matching will be performed on gender, age at the start of ATI (+/- 5 years, or age of first included sampling if no ATI performed), current CD4+ (+/- 25%, at the start of ATI or first included sampling if no ATI performed) and total years on ART if possible (+/-1 year, if <5 years on ART. If >5 years on ART: +/- 2 years), if possible. When matching on all criteria is impossible, in order of priority, matching will be done on total years on ART, gender, CD4 T-cell count, age.
Who may be able to join
- 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.
Who cannot join
- 1.Documented refusal of data use for research
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Biomarkers for Post-treatment Control in HIV: International Multicenter Study of the EU2Cure Research Consortium (EU2Control)
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.
Read the detailed description
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.
- Conditions
- HIV
- Being tested
- No Intervention: Observational Cohort
- Keywords
- HIV, Post-treatment control, Post-intervention control, biobank, biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention (observational cohort)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No Intervention: Observational Cohort | |
| 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. Receives: Other: No Intervention: Observational Cohort | |
| Controls | non-controllers (NC) with plasma HIV-RNA >1000 c/mL after ART interruption Receives: Other: No Intervention: Observational Cohort | |
| 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. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intact proviral HIV DNA reservoir size in PTC and PIC before and during ATI
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.
Measured: 1 year
Total integrated HIV DNA reservoir size in PTC and PIC before and during ATI
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.
Measured: 1 year
Inducible HIV reservoir size in PTC and PIC before and during ATI
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.
Measured: 1 year
Time from the start of ATI until first measurement of HIV RNA >50 copies/mL in PTC and PIC.
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).
Measured: 1 year
Time from the start of ATI until first measurement of HIV RNA >400 copies/mL in PTC and PIC.
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).
Measured: 1 year
Time from the start of ATI until first measurement of HIV RNA > 1000 copies/mL in PTC and PIC.
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).
Measured: 1 year
Number and severity of adverse events during and after ATI.
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.
Measured: 1 year
Biobank with samples from PTC, PIC and NC including sampling time points and material available.
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.
Measured: 1 year from screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- EU2Cure consortium, Radboud University Medical Center, European Aids Treatment Group (EATG), Brussels, Belgium, University Hospital, Ghent, University Ghent, Oslo University Hospital, Charite University, Berlin, Germany, Institut Pasteur, University of Aarhus, IrsiCaixa, Fundació Lluita contra les Infeccions, IRCCS San Raffaele, Imperial College London, University of Oxford, Guy's and St Thomas' NHS Foundation Trust, Chelsea and Westminster NHS Foundation Trust, Pomeranian Medical University Szczecin, Hospital Universitari Vall d'Hebron Research Institute, Medical University of Warsaw, Centre Hospitalier Universitaire Vaudois
- Responsible party
- Principal investigator, Casper Rokx, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692295
- Sponsor's protocol ID
- MEC-2024-0338
- Other IDs
- CO-US-985-7598
- Acronym
- EU2Control
- Status last verified
- Jul 2026
- First submitted
- 29 May 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Post-treatment Control in HIV: International Multicenter Study of the EU2Cure Research Consortium (EU2Control)
- ClinicalTrials.gov ID
- NCT07692295
- Acronym / sponsor ID
- EU2Control / MEC-2024-0338
- Conditions
- HIV
- Keywords
- HIV, Post-treatment control, Post-intervention control, biobank, biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- EU2Cure consortium, Radboud University Medical Center, European Aids Treatment Group (EATG), Brussels, Belgium, University Hospital, Ghent, University Ghent, Oslo University Hospital, Charite University, Berlin, Germany, Institut Pasteur, University of Aarhus, IrsiCaixa, Fundació Lluita contra les Infeccions, IRCCS San Raffaele, Imperial College London, University of Oxford, Guy's and St Thomas' NHS Foundation Trust, Chelsea and Westminster NHS Foundation Trust, Pomeranian Medical University Szczecin, Hospital Universitari Vall d'Hebron Research Institute, Medical University of Warsaw, Centre Hospitalier Universitaire Vaudois
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PTC | – | Other: No Intervention: Observational CohortViremic 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 |
| Post intervention controller (PIC) | – | Other: No Intervention: Observational CohortPWH 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. |
| Controls | – | Other: No Intervention: Observational Cohortnon-controllers (NC) with plasma HIV-RNA >1000 c/mL after ART interruption |
| Suppressors | – | Other: No Intervention: Observational Cohortviremic 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People living with HIV meeting PTC inclusion criteria from previous ATI trials. In addition, PTC from routine care will be identified and included. Non controllers will be identified from ATI trials and routine care. To analyse the reservoir size, PTC (both from routine care and ATI trials) will be matched in a 1:1 ratio with non-controllers (NC). We will also match NC to a control group of people living with HIV who did not undergo an ATI (Suppressors). Matching will be performed on gender, age at the start of ATI (+/- 5 years, or age of first included sampling if no ATI performed), current CD4+ (+/- 25%, at the start of ATI or first included sampling if no ATI performed) and total years on ART if possible (+/-1 year, if <5 years on ART. If >5 years on ART: +/- 2 years), if possible. When matching on all criteria is impossible, in order of priority, matching will be done on total years on ART, gender, CD4 T-cell count, age.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1.Documented refusal of data use for research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo intervention (observational cohort) | Other | Controls, PTC, Post intervention controller (PIC), Suppressors |
Primary outcome
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.
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.
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.
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).
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).
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).
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Erasmus Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Casper Rokx (+31618069137, c.rokx@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intact proviral HIV DNA reservoir size in PTC and PIC before and during ATI (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.