Tracking and Exploring the Source of Viral REbound

NCT ID: NCT03117985

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-13

Study Completion Date

2019-04-29

Brief Summary

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

Detailed Description

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Conditions

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Hiv

Keywords

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HIV reservoirs HIV persistence Viral rebound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Antiretroviral therapy

Stopping antiretroviral therapy

Group Type EXPERIMENTAL

no drug

Intervention Type OTHER

Stopping antiretroviral therapy

Interventions

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no drug

Stopping antiretroviral therapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoire de Virologie Moléculaire de Montpellier

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LAURENT HOCQUELOUX

Role: STUDY_DIRECTOR

CHR ORLEANS

Locations

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Chr Orleans

Orléans, , France

Site Status

Countries

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France

References

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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;543(7646):564-567. doi: 10.1038/nature21710. Epub 2017 Mar 15.

Reference Type RESULT
PMID: 28297712 (View on PubMed)

Other Identifiers

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CHRO 2016-05

Identifier Type: -

Identifier Source: org_study_id