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RecruitingNCT03449706ACSUpdated Sep 17, 2026

Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection

An observational study in HIV and Seroconversion, HIV, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by University Hospital, Ghent · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • HIV
  • Seroconversion, HIV

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Keywords

  • Reservoir
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

We will enroll a minimum of 30 patients and a maximum of 70 participants (Fiebig stages I - VI) in the study to establish a cohort of early treated patients. We aim at including at least 15 people with an incomplete Western Blot (Fiebig I->IV) and as a control we will also include patients with complete Western Blot and history of a semi-recent infection (Fiebig V-VI).

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 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).
  • 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.
  • Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease.
  • Current history of cancer.
  • Pregnancy or breastfeeding.
  • 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.
  • Previous participation in a trial evaluating an immune modulating agent
  • 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
  • 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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • DrugEarly combination anti-retroviral treatment

    Patients are started on treatment to supress the HIV virus in the phase of acute seroconversion.

05

What researchers measure

Primary outcomes

  1. Evolution of virological and immunological parameters of the HIV reservoir in recently infected HIV positive patients that started treatment during acute seroconversion.

    Virological, immunological and gene expression analysis on blood and tissue from in depth sampling.

    Time frame: 10 years

Secondary outcomes

  1. Evolution of microbiome in recently infected HIV positive patients that started treatment during acute seroconversion.

    Microbiome analysis on stoolsamples.

    Time frame: 10 years

06

Study locations

1 of 1 sites recruiting
  • UZ Gent
    Ghent, Oost-Vlaanderen 9000, Belgium
    • Linos Vandekerckhove, Prof. Dr. · Contact · linos.vandekerchove@ugent.be · +3293323398
    • Linos Vandekerckhove, Prof. · Principal investigator
    Recruiting
07

References and documents

Study documents

  • Study protocol · Jan 31, 2018
  • Informed consent form · Jul 14, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03449706
Lead sponsor
University Hospital, Ghent
Collaborators
ViiV Healthcare
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Sep 1, 2017
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Linos Vandekerckhove, Prof. Dr.
Contact
linos.vandekerckhove@ugent.be
+3293323398
Linos Vandekerckhove, Prof. Dr.
principal investigator · University Hospital, Ghent

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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