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NCT03449706Recruiting

Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection

Source: ClinicalTrials.gov · Last updated 17 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
70 (estimated)
First submitted
22 Feb 2018
Start date
1 Sept 2017
Primary completion date
1 Jan 2028
Lead sponsor
University Hospital, Ghent
Diseases
HIV
NCT number
NCT03449706

What you commit to

  • Study type: Observational
  • Planned participants: 70
  • From 1 Sept 2017 to the primary completion date, 1 Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous or current history of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification), consisting of chronic HIV-1 infection.
  • Evidence of active HCV infection: HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry.
  • Previous participation in a trial evaluating an immune modulating agent
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry.

Other illness

  • Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (=HBV antigen or viral load negative and positive HBV surface antibody).
  • Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease.
  • Current history of cancer.
  • Any conditions, including psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant.

Lab values

  • Abnormal laboratory tests results at screening: confirmed Hemoglobin \<11g/dl for women and \<12 g:dl for men/ confirmed platelet count \< 100000/l / confirmed neutrophil count \<1000/μl/ confirmed AST and/or ALT \> 3xULN

Other

  • Pregnancy or breastfeeding.

Who the study is looking for

  • Documented recent HIV-1 infection, early diagnosis: clinical symptoms of acute seroconversion and incomplete Western Blot OR negative screening test within the past 6 months and incomplete Western Blot OR risk contact within the 3 months and presumable primo-infection with or without clinical symptoms and incomplete Western Blot
  • Able and willing to provide written informed consent
  • Ability to attend the complete schedule of assessments and patient visits for patients participating in option A schedule (described below), or ability to attend a partial schedule of assessments and patient visits for patients participating in option B (described below).
  • Ability and willingness to have blood and tissue samples collected and stored indefinitely and used for various research purposes.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Gent
Coordinator of this site? Confirm its status
GhentBelgiumRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.