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NCT03449706: ACS

Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection

Recruiting now Last updated 14 January 2025
What this trial tests

trial testing Early combination anti-retroviral treatment in HIV in 70 participants. Currently enrolling.

Timeline
1 September 2017
Primary endpoint
1 January 2028
1 January 2028

Quick facts

Lead sponsorUniversity Hospital, Ghent
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment70
Start date1 September 2017
Primary completion1 January 2028
Estimated completion1 January 2028
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Ghent

Who can join

Adults 18 to 65, any sex, with HIV or Seroconversion, HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this prospective longitudinal study we aim to assess how immunologic and viral aspects of the human immunodeficiency virus (HIV) viral reservoir, established during early HIV infection and responsible for viral rebound at treatment interruption, evolve in individuals who start combination anti-retroviral therapy (cART) during acute seroconversion. Recently infected patients will be selected based on Fiebig staging for an in depth sampling protocol at different timepoints during a 2 year follow up period. Colonbiopsies, lymphnode resection, lumbar puncture, leucapheresis and repeated peripheral venous blood-draws will be performed. Immunological, virological and genome expression analysis will be performed on the gathered samples.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. In-depth virological and immunological characterization of HIV-1 cure after CCR5Δ32/Δ32 allogeneic hematopoietic stem cell transplantation.
    Jensen BO, Knops E, Cords L, Lübke N, et al · · 2023 · cited 126× · PMID 36807684 · DOI 10.1038/s41591-023-02213-x
  2. Longitudinal patterns of inflammatory mediators after acute HIV infection correlate to intact and total reservoir.
    De Clercq J, De Scheerder MA, Mortier V, Verhofstede C, et al · · 2023 · cited 17× · PMID 38250083 · DOI 10.3389/fimmu.2023.1337316
  3. Cohort profile: the Netherlands Cohort Study on Acute HIV infection (NOVA), a prospective cohort study of people with acute or early HIV infection who immediately initiate HIV treatment.
    Dijkstra M, Prins H, Prins JM, Reiss P, et al · · 2021 · cited 9× · PMID 34845066 · DOI 10.1136/bmjopen-2020-048582
  4. Evolution of the HIV-1 integration site landscape and inducible reservoir in early-treated people.
    Struyve T, Pardons M, De Clercq J, Termote L, et al · · 2025 · cited 1× · PMID 41289275 · DOI 10.1371/journal.ppat.1013702
  5. Staging of immuno-virological dynamics during acute HIV infection in a Belgian prospective cohort study.
    De Clercq J, De Scheerder MA, Vanherrewege S, Caluwé E, et al · · 2024 · cited 1× · PMID 39403428 · DOI 10.1016/j.jve.2024.100392

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