Tracking and Exploring the Source of Viral REbound

Not Applicable

Terminated

• Conditions: Hiv
• Interventions: Other: no drug

• Registration Number: NCT03117985
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-13
• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-18
• Primary Completion: 2019-04-29
• Study Completion: 2019-04-29
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-27
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antiretroviral therapy	no drug	Stopping antiretroviral therapy

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chr Orleans; 🇫🇷 Orleans, France