HivTESOVIRNCT03117985

Tracking and Exploring the Source of Viral REbound

A study testing no drug in people with Hiv, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hiv
What is being tested?: no drug
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteFrance
Study dates: 13 Feb 2017to 29 Apr 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

- 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

Show all 11Show fewer

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.

Who cannot join

- Acquired Immune Deficiency Syndom (AIDS)
Pregnancy
Human immunodeficiency virus (HIV)-2 co infection
Thrombopenia
Neurological events during primary infection
Hepatitis B + (HBV+)

Show all 20Show fewer

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 locations and contacts

1 site in 1 country.

France1 site

Chr Orleans
Orléans, 45067

Other trials in France

About this study

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

Conditions: Hiv
Being tested: no drug
Keywords: HIV reservoirs, HIV persistence, Viral rebound
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

no drugOther
Stopping antiretroviral therapy

Study groups in NCT03117985
Study group	Role	What they receive
Antiretroviral therapy	Experimental	Stopping antiretroviral therapy Receives: Other: no drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 201729 Apr 2019

First posted18 Apr 2017
Study start13 Feb 2017
Primary completion29 Apr 2019
Study completion29 Apr 2019

Why it stopped: no interesting results

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HivStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03117985
Sponsor's protocol ID: CHRO 2016-05
Acronym: TESOVIR
Status last verified: Dec 2022
First submitted: 24 Mar 2017
Last updated: 29 Dec 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 28297712

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
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PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse

All Hiv trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tracking and Exploring the Source of Viral REbound
ClinicalTrials.gov ID: NCT03117985
Acronym / sponsor ID: TESOVIR / CHRO 2016-05
Conditions: Hiv
Keywords: HIV reservoirs, HIV persistence, Viral rebound
Study type: Interventional
Recruitment status: TerminatedReason stopped: no interesting results
Enrolment: 5 participants (actual)
Lead sponsor: Centre Hospitalier Régional d'OrléansUniversity, hospital or other
Collaborators: Laboratoire de Virologie Moléculaire de Montpellier
Study start: 13 Feb 2017 (actual)
Primary completion: 29 Apr 2019 (actual)
Study completion: 29 Apr 2019 (actual)
First posted: 18 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Antiretroviral therapy	Experimental	Other: no drugStopping antiretroviral therapy

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

- 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

Key exclusion criteria (20 listed)

- Acquired Immune Deficiency Syndom (AIDS)
Pregnancy
Human immunodeficiency virus (HIV)-2 co infection
Thrombopenia
Neurological events during primary infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
no drugStopping antiretroviral therapy	Other	Antiretroviral therapy

Primary outcome

Genetic Cartography
Time frame: Week 1
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
Genetic Cartography
Time frame: Week 2
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
Genetic Cartography
Time frame: Week 3
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
Genetic Cartography
Time frame: Week 4
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
Genetic Cartography
Time frame: Week 5
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
Genetic Cartography
Time frame: Week 6
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
Genetic Cartography
Time frame: Week 8
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
Genetic Cartography
Time frame: Week 10
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
Genetic Cartography
Time frame: 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

Results and safety

The study was stopped early (reason given: no interesting results). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
Results publication: PubMed 28297712Descours 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.
Individual participant dataSharing planned: No

Related trials for Hiv

RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

LAURENT HOCQUELOUX study director

CHR ORLEANS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing no drug in people with Hiv, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: no interesting results). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Genetic Cartography (time frame: Week 1). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03117985, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.