Tracking and Exploring the Source of Viral REbound (TESOVIR)

Centre Hospitalier Régional d'Orléans

Status: Terminated

Conditions: Hiv

Treatments: Other: no drug

Study type: Interventional

Funder types: Other

Identifiers

NCT03117985

CHRO 2016-05

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Antiretroviral therapy

Experimental group

Description:

Stopping antiretroviral therapy

Treatment:

Other: no drug