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Not yet recruiting NCT07692295

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

— Observational HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention: Observational Cohort.
Who it may be relevant to
Registry conditions: HIV. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other No Intervention: Observational Cohort
    No intervention (observational cohort)

Primary outcome measures

  • Intact proviral HIV DNA reservoir size in PTC and PIC before and during ATI [Time frame: 1 year]
  • Total integrated HIV DNA reservoir size in PTC and PIC before and during ATI [Time frame: 1 year]
  • Inducible HIV reservoir size in PTC and PIC before and during ATI [Time frame: 1 year]
  • Time from the start of ATI until first measurement of HIV RNA >50 copies/mL in PTC and PIC. [Time frame: 1 year]
  • Time from the start of ATI until first measurement of HIV RNA >400 copies/mL in PTC and PIC. [Time frame: 1 year]
  • Time from the start of ATI until first measurement of HIV RNA > 1000 copies/mL in PTC and PIC. [Time frame: 1 year]
  • Number and severity of adverse events during and after ATI. [Time frame: 1 year]
  • Biobank with samples from PTC, PIC and NC including sampling time points and material available. [Time frame: 1 year from screening]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07692295 · MEC-2024-0338 · CO-US-985-7598

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗