Tracking and Exploring the Source of Viral REbound (TESOVIR)

December 27, 2022 updated by: Centre Hospitalier Régional d'Orléans
Phylogenic analysis of viruses hosted in marker positive reservoir cells including CD32a+ CD4 T lymphocytes and rebounding viruses after treatment interruption

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orleans, France, 45067
        • CHR Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antiretroviral therapy
Stopping antiretroviral therapy
Other: no drug
Stopping antiretroviral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 1
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
Week 2
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
Week 3
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
Week 4
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
Week 5
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
Week 6
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
Week 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
Week 10
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
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Collaborators

Laboratoire de Virologie Moléculaire de Montpellier

Investigators

  • Study Director: LAURENT HOCQUELOUX, CHR Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2017

Primary Completion (Actual)

April 29, 2019

Study Completion (Actual)

April 29, 2019

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 27, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHRO 2016-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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