HIV InfectionEURECANCT02858414
Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients
A study testing additional blood sample in people with HIV Infection, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study evaluates the impact of highly active antiretroviral therapy on the size of the latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- additional blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2015to 4 Oct 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected patients under Highly Active Anti-Retroviral Therapy (HAART) or Naïve from treatment
Who cannot join
- Age limits
- Pregnancy
- Legal restrictions to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients: EURECA (ERANET to Unravel New Roads to Eradication and a Cure for AIDS) Study
This study evaluates the impact of highly active antiretroviral therapy on the size of the latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The activation state of the cells will be assessed, by measuring the activation of Akt, to determine its influence on the size of the viral reservoirs.
- Conditions
- HIV Infection
- Being tested
- additional blood sample
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| blood sample | Experimental | Not described Receives: Other: additional blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the integrated viral reservoir size
Measure by Alu-PCR. Results are given in number of integrated proviral DNA copies per 1 million cells.
Measured: day 1
Measure of the proviral reservoir size
Measure by Total Proviral HIV DNA detection kit. Results are given in number of total proviral DNA copies per 1 million cells.
Measured: day 1
Secondary outcomes (1)
Measure of Akt activation
Measure of Akt activation in live cells by flow cytometry
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start2 Apr 2015
- Primary completion4 Oct 2017
- Study completion4 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges HERBEIN, MD-PhD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858414
- Sponsor's protocol ID
- P/2014/223
- Acronym
- EURECA
- Status last verified
- Dec 2018
- First submitted
- 29 Jul 2016
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients: EURECA (ERANET to Unravel New Roads to Eradication and a Cure for AIDS) Study
- ClinicalTrials.gov ID
- NCT02858414
- Acronym / sponsor ID
- EURECA / P/2014/223
- Conditions
- HIV Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 2 Apr 2015 (actual)
- Primary completion
- 4 Oct 2017 (actual)
- Study completion
- 4 Oct 2017 (actual)
- First posted
- 8 Aug 2016 (estimated)
- 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.
This study evaluates the impact of highly active antiretroviral therapy on the size of the latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The activation state of the cells will be assessed, by measuring the activation of Akt, to determine its influence on the size of the viral reservoirs.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood sample | Experimental | Other: additional blood sample |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV infected patients under Highly Active Anti-Retroviral Therapy (HAART) or Naïve from treatment
Key exclusion criteria (3 listed)
- Age limits
- Pregnancy
- Legal restrictions to consent
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 |
|---|---|---|
| additional blood sample | Other | blood sample |
Primary outcome
Measure of the integrated viral reservoir size
Time frame: day 1
Measure by Alu-PCR. Results are given in number of integrated proviral DNA copies per 1 million cells.
Measure of the proviral reservoir size
Time frame: day 1
Measure by Total Proviral HIV DNA detection kit. Results are given in number of total proviral DNA copies per 1 million cells.
1 secondary outcome
Measure of Akt activation
Time frame: day 1
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 6 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Georges HERBEIN, MD-PhD principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional blood sample in people with HIV Infection, run by Centre Hospitalier Universitaire de Besancon 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 1 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 6 Dec 2018. 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?
Measure of the integrated viral reservoir size (time frame: day 1). The study lists 2 primary outcomes in all. 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 6 Dec 2018.