Tracking and Exploring the Source of Viral REbound

Hiv Clinical Trial

— TESOVIR  

Official title:

Tracking and Exploring the Source of Viral REbound

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03117985
• Other study ID #: CHRO 2016-05
• Status: Terminated
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: April 29, 2019

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 29, 2019
• Est. primary completion date: April 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

Other:
• no drug
Stopping antiretroviral therapy

Locations

Country	Name	City	State
France	Chr Orleans	Orleans

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans	Laboratoire de Virologie Moléculaire de Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

Descours B, Petitjean G, Lopez-Zaragoza JL, Bruel T, Raffel R, Psomas C, Reynes J, Lacabaratz C, Levy Y, Schwartz O, Lelievre JD, Benkirane M. CD32a is a marker of a CD4 T-cell HIV reservoir harbouring replication-competent proviruses. Nature. 2017 Mar 23 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic Cartography	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
Primary	Genetic Cartography	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
Primary	Genetic Cartography	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
Primary	Genetic Cartography	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
Primary	Genetic Cartography	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
Primary	Genetic Cartography	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
Primary	Genetic Cartography	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
Primary	Genetic Cartography	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
Primary	Genetic Cartography	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