HIV InfectionsANRS EP63NCT03298360
A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a
An observational study of HIV Infections, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Blood sample
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2018to 25 Jun 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV Infection
Who may be able to join
- Patients who participated to ANRS139 TRIO trial, and still followed in centers
- Who remained in virological success since the participation at the trial: 90% of HIV-1 RNA level less than 50 copies/mL : one or more blips less than 1000 copies/mL are tolerated
- Genotypic resistance profiles available at baseline and before trial
- Age ≥ 18 years
- Affiliate or beneficiary of a social security system (the State Medical Aid or AME is not a social security system).
- Written informed consent signed by the person and the investigator before any exam performed in the study.
Who cannot join
- HIV-1 RNA level ≥ 1000 copies/mL at least once since the end of the 139 TRIO trial
- Patient participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit.
- Person under legal guardianship or deprived of liberty by a judicial or administrative decision.
Trial locations and contacts
1 site in 1 country.
About this study
To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.
Read the detailed description
Objectives
Principal objective
To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.
Secondary objectives
To analyze the HIV viral sequences present in the CD4 + lymphocytes with other membrane HIV reservoir markers, currently being identified, in these same patients
Methodology
Pathophysiological study, in patients infected by multi drug-resistant viruses
Estimated enrollment
21 participants (total and per group)
Intervention
167mL blood sample in EDTA tube:
- 160mL (16 tubes of 10mL): for IGH (Institute of Human Genetics-Montpellier)
- 7mL (1tube of 7mL): to measure HIV-RNA in centers
Estimated planning or Study / Trial timetable
Study start date: September 2017
Enrollment period: 12 months
Total study duration: 24 months (analyses included)
Estimated study/trial completion date: September 2019 (one year after enrollment of the last patient)
Study design
Cross-sectional survey, 167mL of blood in EDTA tube will be obtained on a research visit, after signature of written informed consent
- Conditions
- HIV Infections
- Being tested
- Blood sample
- Keywords
- HIV cell reservoir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
167mL of blood in EDTA tube will be obtained on a research visit, after signature of written informed consent
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of HIV viral sequences in the CD32 + CD4a + T lymphocytes of the patients
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start28 Jun 2018
- Primary completion25 Jun 2019
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298360
- Sponsor's protocol ID
- ANRS EP63 RESTA 32a
- Acronym
- ANRS EP63
- Status last verified
- Dec 2020
- First submitted
- 20 Sep 2017
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a
- ClinicalTrials.gov ID
- NCT03298360
- Acronym / sponsor ID
- ANRS EP63 / ANRS EP63 RESTA 32a
- Conditions
- HIV Infections
- Keywords
- HIV cell reservoir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 2 Oct 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.
To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.
Detailed description
Objectives
Principal objective
To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.
Secondary objectives
To analyze the HIV viral sequences present in the CD4 + lymphocytes with other membrane HIV reservoir markers, currently being identified, in these same patients
Methodology
Pathophysiological study, in patients infected by multi drug-resistant viruses
Estimated enrollment
21 participants (total and per group)
Intervention
167mL blood sample in EDTA tube:
- 160mL (16 tubes of 10mL): for IGH (Institute of Human Genetics-Montpellier)
- 7mL (1tube of 7mL): to measure HIV-RNA in centers
Estimated planning or Study / Trial timetable
Study start date: September 2017
Enrollment period: 12 months
Total study duration: 24 months (analyses included)
Estimated study/trial completion date: September 2019 (one year after enrollment of the last patient)
Study design
Cross-sectional survey, 167mL of blood in EDTA tube will be obtained on a research visit, after signature of written informed consent
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV Infection
Key inclusion criteria (6 listed)
- Patients who participated to ANRS139 TRIO trial, and still followed in centers
- Who remained in virological success since the participation at the trial: 90% of HIV-1 RNA level less than 50 copies/mL : one or more blips less than 1000 copies/mL are tolerated
- Genotypic resistance profiles available at baseline and before trial
- Age ≥ 18 years
- Affiliate or beneficiary of a social security system (the State Medical Aid or AME is not a social security system).
Key exclusion criteria (3 listed)
- HIV-1 RNA level ≥ 1000 copies/mL at least once since the end of the 139 TRIO trial
- Patient participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit.
- Person under legal guardianship or deprived of liberty by a judicial or administrative decision.
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 |
|---|---|---|
| Blood sample167mL of blood in EDTA tube will be obtained on a research visit, after signature of written informed consent | Other | – |
Primary outcome
Presence of HIV viral sequences in the CD32 + CD4a + T lymphocytes of the patients
Time frame: inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by ANRS, Emerging Infectious Diseases 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 8 Dec 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence of HIV viral sequences in the CD32 + CD4a + T lymphocytes of the patients (time frame: inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2020.