NCT03117985

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 24, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2019

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

2.2 years

First QC Date

March 24, 2017

Last Update Submit

December 27, 2022

Conditions

Hiv

Keywords

HIV reservoirsHIV persistenceViral rebound

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Antiretroviral therapy

EXPERIMENTAL

Stopping antiretroviral therapy

Other: no drug

Interventions

no drugOTHER

Stopping antiretroviral therapy

Antiretroviral therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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
  • 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.

You may not qualify if:

  • \- 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chr Orleans

Orléans, 45067, France

Location

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

    PMID: 28297712RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • LAURENT HOCQUELOUX

    CHR ORLEANS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2017

First Posted

April 18, 2017

Study Start

February 13, 2017

Primary Completion

April 29, 2019

Study Completion

April 29, 2019

Last Updated

December 29, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)