Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection

Last updated: January 13, 2025
Sponsor: University Hospital, Ghent
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Hiv/aids

Hiv Infections

Treatment

Early combination anti-retroviral treatment

Clinical Study ID

NCT03449706
ACS
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented recent HIV-1 infection, early diagnosis: clinical symptoms of acuteseroconversion and incomplete Western Blot OR negative screening test within thepast 6 months and incomplete Western Blot OR risk contact within the 3 months andpresumable primo-infection with or without clinical symptoms and incomplete WesternBlot

  • Able and willing to provide written informed consent

  • Ability to attend the complete schedule of assessments and patient visits forpatients participating in option A schedule (described below), or ability to attenda partial schedule of assessments and patient visits for patients participating inoption B (described below).

  • Ability and willingness to have blood and tissue samples collected and storedindefinitely and used for various research purposes.

Exclusion

Exclusion Criteria:

  • Previous or current history of opportunistic infection (AIDS defining events asdefined in category C of the CDC clinical classification), consisting of chronicHIV-1 infection.

  • Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viralload positive in the past and no evidence of subsequent seroconversion (=HBV antigenor viral load negative and positive HBV surface antibody).

  • Evidence of active HCV infection: HCV antibody positive result within 60 days priorto study entry with positive HCV viral load or, if the HCV antibody result isnegative, a positive HCV RNA result within 60 days prior to study entry.

  • Current or known history of cardiomyopathy or significant ischemic orcerebrovascular disease.

  • Current history of cancer.

  • Pregnancy or breastfeeding.

  • Any conditions, including psychiatric and psychological disorders, which will in theopinion of the investigator interfere with the trial conduct or safety of theparticipant.

  • Previous participation in a trial evaluating an immune modulating agent

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

  • Active drug or alcohol use or dependence that, in the opinion of the siteinvestigator, would interfere with adherence to study requirements.

  • Acute or serious illness, in the opinion of the site investigator, requiringsystemic treatment and/or hospitalization within 60 days prior to entry.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Early combination anti-retroviral treatment
Phase:
Study Start date:
September 01, 2017
Estimated Completion Date:
January 01, 2028

Connect with a study center

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

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