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Tracking and Exploring the Source of Viral REbound (TESOVIR)

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ClinicalTrials.gov Identifier: NCT03117985
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Laboratoire de Virologie Moléculaire de Montpellier
Information provided by (Responsible Party):
Centre Hospitalier Régional d'Orléans

Brief Summary:
Phylogenic analysis of viruses hosted in marker positive reservoir cells including CD32a+ CD4 T lymphocytes and rebounding viruses after treatment interruption

Condition or disease Intervention/treatment Phase
Hiv Other: no drug Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Tracking and Exploring the Source of Viral REbound
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Antiretroviral therapy
Stopping antiretroviral therapy
Other: no drug
Stopping antiretroviral therapy




Primary Outcome Measures :
  1. Genetic Cartography [ Time Frame: Week 1 ]
    Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

  2. Genetic Cartography [ Time Frame: Week 2 ]
    Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

  3. Genetic Cartography [ Time Frame: Week 3 ]
    Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

  4. Genetic Cartography [ Time Frame: Week 4 ]
    Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

  5. Genetic Cartography [ Time Frame: Week 5 ]
    Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

  6. Genetic Cartography [ Time Frame: Week 6 ]
    Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

  7. Genetic Cartography [ Time Frame: Week 8 ]
    Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

  8. Genetic Cartography [ Time Frame: Week 10 ]
    Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

  9. Genetic Cartography [ Time Frame: Week 12 ]
    Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Age>18year old
  • Nadir CD4>200/mm3
  • CD4/CD8 ratio> 0.5
  • Continuous antiretroviral therapy for more than 2 years
  • Plasma Human Immunodeficiency Virus (HIV) 1 Ribonucleic acid (RNA) <50 copies/ml in the last 2 years
  • Viral Load (VL)<20copies at inclusion
  • Patients who are willing to participate and who understand the trial (particularly, the obligation to have protected intercourse during the study).
  • Informed consent
  • Short half-life treatment
  • Health insurance
  • A subset of CD4 (T4cells) express CD32a.

Exclusion Criteria:

  • - Acquired Immune Deficiency Syndom (AIDS)
  • Pregnancy
  • Human immunodeficiency virus (HIV)-2 co infection
  • Thrombopenia
  • Neurological events during primary infection
  • Hepatitis B + (HBV+)
  • Hepatitis C + (HCV+)
  • Cancer during the last 5 years.
  • Life expectancy < 12 months
  • Autoimmunity
  • Acute infectious disease in the last 60 days.
  • Hemoglobin<7g/dl
  • Glomerular filtration < 60ml/min
  • Refusing protected intercourse
  • Risk of HIV transmission
  • Psychiatric disorders.
  • Alcool and drug abuse
  • Involvement in another clinical trial evaluating a therapeutic.
  • Being under tutorship
  • Being deprived of liberty

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): NCT03117985


Contacts
Contact: DESPUJOLS Aurélie +33238744071 aurelie.despujols@chr-orleans.fr

Locations
France
Chr Orleans Recruiting
Orleans, France, 45067
Contact: HOCQUELOUX Laurent, MD       laurent.hocqueloux@chr-orleans.fr   
Principal Investigator: HOCQUELOUX Laurent, MD         
Sub-Investigator: PRAZUCK Thierry, MD         
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Laboratoire de Virologie Moléculaire de Montpellier
Investigators
Study Director: LAURENT HOCQUELOUX CHR ORLEANS

Publications of Results:
Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT03117985     History of Changes
Other Study ID Numbers: CHRO 2016-05
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Régional d'Orléans:
HIV reservoirs
HIV persistence
Viral rebound