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TESOVIR: Tracking and Exploring the Source of Viral REbound

Sponsor
Centre Hospitalier Régional d'Orléans (Other)
Overall Status
Recruiting
CT.gov ID
NCT03117985
Collaborator
Laboratoire de Virologie Moléculaire de Montpellier (Other)
10
Enrollment
1
Location
1
Arm
66.6
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: no drug
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
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 :
Feb 13, 2017
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Antiretroviral therapy

Stopping antiretroviral therapy

Other: no drug
Stopping antiretroviral therapy

Outcome Measures

Primary Outcome Measures

  1. Genetic Cartography [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 [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 [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chr Orleans Orleans France 45067

Sponsors and Collaborators

  • Centre Hospitalier Régional d'Orléans
  • Laboratoire de Virologie Moléculaire de Montpellier

Investigators

  • Study Director: LAURENT HOCQUELOUX, CHR ORLEANS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier:
NCT03117985
Other Study ID Numbers:
  • CHRO 2016-05
First Posted:
Apr 18, 2017
Last Update Posted:
Nov 3, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Nov 3, 2021