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Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection (ACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03449706
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : December 2, 2022
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Algemene Inwendige Ziekten, University Hospital, Ghent

Study Description
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Brief 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.


Condition or disease Intervention/treatment
HIV Seroconversion, HIV Drug: Early combination anti-retroviral treatment

Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : January 1, 2028
Estimated Study Completion Date : January 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Intervention Details:
  • Drug: Early combination anti-retroviral treatment
    Patients are started on treatment to supress the HIV virus in the phase of acute seroconversion.

Outcome Measures
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Primary Outcome Measures :
  1. Evolution of virological and immunological parameters of the HIV reservoir in recently infected HIV positive patients that started treatment during acute seroconversion. [ Time Frame: 10 years ]
    Virological, immunological and gene expression analysis on blood and tissue from in depth sampling.


Secondary Outcome Measures :
  1. Evolution of microbiome in recently infected HIV positive patients that started treatment during acute seroconversion. [ Time Frame: 10 years ]
    Microbiome analysis on stoolsamples.


Biospecimen Retention:   Samples With DNA
  • Colon biopsy
  • Lymph node biopsy
  • Cerebrospinal fluids
  • Whole blood
  • Leukapheresis apherate
  • Stool

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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).
Criteria

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:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449706


Contacts
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Contact: Linos Vandekerckhove, Prof. Dr. +3293323398 linos.vandekerckhove@ugent.be

Locations
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Belgium
UZ Gent Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Linos Vandekerckhove, Prof. Dr.    +3293323398    linos.vandekerchove@ugent.be   
Principal Investigator: Linos Vandekerckhove, Prof.         
Sponsors and Collaborators
University Hospital, Ghent
ViiV Healthcare
Investigators
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Principal Investigator: Linos Vandekerckhove, Prof. Dr. University Hospital, Ghent
  Study Documents (Full-Text)

Documents provided by Algemene Inwendige Ziekten, University Hospital, Ghent:
Study Protocol  [PDF] January 31, 2018
Informed Consent Form  [PDF] July 14, 2017

More Information
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Responsible Party: Algemene Inwendige Ziekten, Professor Doctor, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03449706    
Other Study ID Numbers: ACS
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Algemene Inwendige Ziekten, University Hospital, Ghent:
Reservoir
Additional relevant MeSH terms:
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HIV Infections
HIV Seropositivity
Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
 RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents