HIV-infected PatientsPRIMIMMUNONCT02827227
Values of the Immune Activation Markers CD38 and HLA-DR and the Ratio CD4/CD8 According to the Delay of Combined AntiRetroviral Therapy (c-ART) Initiation in Primary HIV-infected Patients (PRIMIMMUNO)
An observational study of HIV-infected Patients, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The objective was to identify factors associated with the normalization of the CD4/CD8 ratio (>=1) in patients with a history of primary HIV infection (PHI) and long-term combined antiretroviral therapy (cART). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-infected Patients
- What is being tested?
- lymphocytes immunophenotyping
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Feb 2016
- 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 patients
Who may be able to join
- all HIV patients with a known history of PHI and a minimum of 2 years of effective cART (< 200 copies/mL) without interruption or virological failure
Who cannot join
- Patients with hepatitis C or B virus co-infection or with a history of neoplasia or immunosuppressive therapy after the date of PIH
Trial locations and contacts
1 site in 1 country.
About this study
The objective was to identify factors associated with the normalization of the CD4/CD8 ratio (>=1) in patients with a history of primary HIV infection (PHI) and long-term combined antiretroviral therapy (cART).
- Conditions
- HIV-infected Patients
- Being tested
- lymphocytes immunophenotyping
- Keywords
- HIV-infected patients, cART, immune restoration, markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphocytes immunophenotypingBiological
The lymphocytes immunophenotyping were performed from fresh EDTA-anticoagulated blood harvested during a routine follow-up of patients in HIV Lyon centers.
HIV patients with a known history of PHI and a minimum of 2 years of effective cART (< 200 copies/mL) without interruption or virological failure were included in 2 centers in Lyon (Croix-Rousse and Edouard Herriot hospital).
Baseline factors at the time of PHI, delay, type and duration of first and duration of total cART, CMV status, nadir CD4 cells count and level of activation markers on CD4 and CD8 cells (CD38 and HLA-DR) at the time of the study were assessed.
Patients with hepatitis C or B virus co-infection or with a history of neoplasia or immunosuppressive therapy after the date of PIH were excluded.
| Study group | Role | What they receive |
|---|---|---|
| Primary HIV- Infected patients | Primary HIV- Infected patients with a minimum of 2 years of effective cART. Receives: Biological: lymphocytes immunophenotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of CD4+ and CD8+ T lymphocytes with activation markers (CD38 + and HLA-DR)
percentage of CD4+ and CD8+ T lymphocytes with activation markers (CD38 + and HLA-DR) according to the delay of cART initiation (early 3 months or delayed > 3 months).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infected PatientsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827227
- Sponsor's protocol ID
- D21969
- Acronym
- PRIMIMMUNO
- Status last verified
- Jul 2016
- First submitted
- 4 Jul 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Values of the Immune Activation Markers CD38 and HLA-DR and the Ratio CD4/CD8 According to the Delay of Combined AntiRetroviral Therapy (c-ART) Initiation in Primary HIV-infected Patients (PRIMIMMUNO)
- ClinicalTrials.gov ID
- NCT02827227
- Acronym / sponsor ID
- PRIMIMMUNO / D21969
- Conditions
- HIV-infected Patients
- Keywords
- HIV-infected patients, cART, immune restoration, markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Jul 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.
The objective was to identify factors associated with the normalization of the CD4/CD8 ratio (>=1) in patients with a history of primary HIV infection (PHI) and long-term combined antiretroviral therapy (cART).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary HIV- Infected patients | – | Biological: lymphocytes immunophenotypingPrimary HIV- Infected patients with a minimum of 2 years of effective cART. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV patients
Key inclusion criteria (1 listed)
- all HIV patients with a known history of PHI and a minimum of 2 years of effective cART (< 200 copies/mL) without interruption or virological failure
Key exclusion criteria (1 listed)
- Patients with hepatitis C or B virus co-infection or with a history of neoplasia or immunosuppressive therapy after the date of PIH
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 |
|---|---|---|
| lymphocytes immunophenotypingThe lymphocytes immunophenotyping were performed from fresh EDTA-anticoagulated blood harvested during a routine follow-up of patients in HIV Lyon centers. HIV patients with a known history of PHI and a minimum of 2 years of effective cART (< 200 copies/mL) without interruption or virological failure were included in 2 centers in Lyon (Croix-Rousse and Edouard Herriot hospital). Baseline factors at the time of PHI, delay, type and duration of first and duration of total cART, CMV status, nadir CD4 cells count and level of activation markers on CD4 and CD8 cells (CD38 and HLA-DR) at the time of the study were assessed. Patients with hepatitis C or B virus co-infection or with a history of neoplasia or immunosuppressive therapy after the date of PIH were excluded. | Biological | Primary HIV- Infected patients |
Primary outcome
percentage of CD4+ and CD8+ T lymphocytes with activation markers (CD38 + and HLA-DR)
Time frame: Day 0
percentage of CD4+ and CD8+ T lymphocytes with activation markers (CD38 + and HLA-DR) according to the delay of cART initiation (early 3 months or delayed > 3 months).
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 12 Jul 2016.
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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-infected Patients, run by Hospices Civils de Lyon 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 1 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 12 Jul 2016. 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?
percentage of CD4+ and CD8+ T lymphocytes with activation markers (CD38 + and HLA-DR) (time frame: Day 0). 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 12 Jul 2016.