Immune DeficiencyACTIVIHNCT02334943
Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment
A study testing Blood test in people with Immune Deficiency and HIV-related Gut Disease - Cause Unknown, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral treatment. This immune activation is responsible for immune deficiency as well as for non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic syndrome or osteoporosis. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immune Deficiency, HIV-related Gut Disease - Cause Unknown, Activation of Latent Virus
- What is being tested?
- Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Mar 2015
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > or = 45 years
- HIV-1 infection
- Number of T CD4+ lymphocytes before antiretroviral treatment < 350 cells/mm3
- Current number of T CD4+ lymphocytes > 200 cells / mm3 for 6 moths before inclusion
- Efficient and well tolerated antiretroviral treatment for more than 24 months
- HIV-1 viral load < 50 copies/ml for more than 24 months before inclusion
Show all 9Show fewer
- Patient able to understand the nature, the objective and the methods of the study
- Patient having signed the informed consent
- Affiliation to French Social Security System
Who cannot join
- Patient having a current evidence of II to IV rank of the ANRS scale clinical condition
- Patient having a current evidence of III to IV rank of the ANRS scale biological condition
- Patient has a current evidence of an active coinfection
- Patient has a current (active) diagnosis of acute hepatitis due to any cause. Patients with chronic hepatitis, including chronic hepatitis B and/or C, may enter the study as long as they have stable liver function tests and undetectable viral load of hepatitis B and/or C
- Patient has a cirrhosis
- Patient presents with a non infectious pathology that might give immune modifications
Show all 9Show fewer
- Patient using immuno-modulator therapy or chemotherapy
- Patient is currently participating or has participated in a study (within the exclusion period defined by this study)
- Patient is pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment: Etiologic Factors, Forms and Potential Association With Chronic Comorbidities Unrelated to Immune Deficiency.
Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral treatment. This immune activation is responsible for immune deficiency as well as for non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic syndrome or osteoporosis. The goal of this observational transversal multicentric study is to establish the etiologic factors of persistent immune activation in treated HIV-1 infected patients (persistent de novo infection of T CD4+ cells, microbial translocation, active coinfections, immunosenescence, T CD4+ cells lymphopenia, Treg deficiency), its different forms ( activation of T CD4+ cells, T CD8+ cells, B cells, NK cells, monocytes, granulocytes, platelets, endothelial cells or general inflammation) and the potential correlation between causes, forms of immune activation and emergent comorbidities (kidney, bone or liver dysfunction, metabolic syndrome).
Read the detailed description
Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral treatment. This immune activation is responsible for immune deficiency as well as for non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic syndrome or osteoporosis. The goal of this observational transversal multicentric study is to establish the etiologic factors of persistent immune activation in treated HIV-1 infected patients (persistent de novo infection of T CD4+ cells, microbial translocation, active coinfections, immunosenescence, T CD4+ cells lymphopenia, Treg deficiency), its different forms ( activation of T CD4+ cells, T CD8+ cells, B cells, NK cells, monocytes, granulocytes, platelets, endothelial cells or general inflammation) and the potential correlation between causes, forms of immune activation and emergent comorbidities (kidney, bone or liver dysfunction, metabolic syndrome). These correlations could highlight physiopathologic mechanisms relating a specific cause of immune activation, activation of a specific subpopulation of immune cells and a comorbidity. Physiopathologic mechanisms could then be tested in vitro and lead into new therapeutic tracks of immune activation secondary to HIV-1 or to the natural ageing process.
- Conditions
- Immune Deficiency, HIV-related Gut Disease - Cause Unknown, Activation of Latent Virus, Other Diagnoses, Comorbidities, and Complications
- Being tested
- Blood test
- Keywords
- Immune Activation, HIV-1 infected subjects, Undetectable viral load, Causes of Immune Activation in HIV-1 infected patients, Forms of Immune Activation, Emergent non-AIDS related comorbidities
- Medical subject headings
- Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
Blood test
| Study group | Role | What they receive |
|---|---|---|
| Treated HIV-1 infected patients | Experimental | Treated HIV-1 infected patients for Blood test Receives: Biological: Blood test |
| No treated HIV-1 infected patients | Experimental | No treated HIV-1 infected patients for Blood test Receives: Biological: Blood test |
| Healthy witness | Experimental | Healthy witness for Blood test Receives: Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection of novo persistent
Etiologic factors of persistent immune activation in treated HIV-1 infected patients (obstinacy of the infection of new cells T CD4 +, microbial translocation, active coinfection, immunosenescence, lymphopenia T CD4 +, deficit in lymphocytes Treg) on a day: the day of the inclusion
Measured: Infection of novo persistent the day of inclusion
Secondary outcomes (2)
Microbial translocation
Microbial translocation (DNA bacterial plasma derivative)
Measured: Microbial translocation the day of inclusion
Diagnosis immunizing activation
Activation T CD4 and T CD8, B, NK
Measured: Diagnosis immunizing activation the day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune DeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JACQUES REYNES, PU PH, Principal investigator, Univerty Hospital Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334943
- Sponsor's protocol ID
- 9187
- Acronym
- ACTIVIH
- Status last verified
- Nov 2015
- First submitted
- 22 Jul 2014
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment: Etiologic Factors, Forms and Potential Association With Chronic Comorbidities Unrelated to Immune Deficiency.
- ClinicalTrials.gov ID
- NCT02334943
- Acronym / sponsor ID
- ACTIVIH / 9187
- Conditions
- Immune Deficiency, HIV-related Gut Disease - Cause Unknown, Activation of Latent Virus, Other Diagnoses, Comorbidities, and Complications
- Keywords
- Immune Activation, HIV-1 infected subjects, Undetectable viral load, Causes of Immune Activation in HIV-1 infected patients, Forms of Immune Activation, Emergent non-AIDS related comorbidities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Jan 2015 (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.
Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral treatment. This immune activation is responsible for immune deficiency as well as for non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic syndrome or osteoporosis. The goal of this observational transversal multicentric study is to establish the etiologic factors of persistent immune activation in treated HIV-1 infected patients (persistent de novo infection of T CD4+ cells, microbial translocation, active coinfections, immunosenescence, T CD4+ cells lymphopenia, Treg deficiency), its different forms ( activation of T CD4+ cells, T CD8+ cells, B cells, NK cells, monocytes, granulocytes, platelets, endothelial cells or general inflammation) and the potential correlation between causes, forms of immune activation and emergent comorbidities (kidney, bone or liver dysfunction, metabolic syndrome).
Detailed description
Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral treatment. This immune activation is responsible for immune deficiency as well as for non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic syndrome or osteoporosis. The goal of this observational transversal multicentric study is to establish the etiologic factors of persistent immune activation in treated HIV-1 infected patients (persistent de novo infection of T CD4+ cells, microbial translocation, active coinfections, immunosenescence, T CD4+ cells lymphopenia, Treg deficiency), its different forms ( activation of T CD4+ cells, T CD8+ cells, B cells, NK cells, monocytes, granulocytes, platelets, endothelial cells or general inflammation) and the potential correlation between causes, forms of immune activation and emergent comorbidities (kidney, bone or liver dysfunction, metabolic syndrome). These correlations could highlight physiopathologic mechanisms relating a specific cause of immune activation, activation of a specific subpopulation of immune cells and a comorbidity. Physiopathologic mechanisms could then be tested in vitro and lead into new therapeutic tracks of immune activation secondary to HIV-1 or to the natural ageing process.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treated HIV-1 infected patients | Experimental | Biological: Blood testTreated HIV-1 infected patients for Blood test |
| No treated HIV-1 infected patients | Experimental | Biological: Blood testNo treated HIV-1 infected patients for Blood test |
| Healthy witness | Experimental | Biological: Blood testHealthy witness for Blood test |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > or = 45 years
- HIV-1 infection
- Number of T CD4+ lymphocytes before antiretroviral treatment < 350 cells/mm3
- Current number of T CD4+ lymphocytes > 200 cells / mm3 for 6 moths before inclusion
- Efficient and well tolerated antiretroviral treatment for more than 24 months
Key exclusion criteria (9 listed)
- Patient having a current evidence of II to IV rank of the ANRS scale clinical condition
- Patient having a current evidence of III to IV rank of the ANRS scale biological condition
- Patient has a current evidence of an active coinfection
- Patient has a current (active) diagnosis of acute hepatitis due to any cause. Patients with chronic hepatitis, including chronic hepatitis B and/or C, may enter the study as long as they have stable liver function tests and undetectable viral load of hepatitis B and/or C
- Patient has a cirrhosis
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 testBlood test | Biological | Healthy witness, No treated HIV-1 infected patients, Treated HIV-1 infected patients |
Primary outcome
Infection of novo persistent
Time frame: Infection of novo persistent the day of inclusion
Etiologic factors of persistent immune activation in treated HIV-1 infected patients (obstinacy of the infection of new cells T CD4 +, microbial translocation, active coinfection, immunosenescence, lymphopenia T CD4 +, deficit in lymphocytes Treg) on a day: the day of the inclusion
2 secondary outcomes
Microbial translocation
Time frame: Microbial translocation the day of inclusion
Diagnosis immunizing activation
Time frame: Diagnosis immunizing activation the day of 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 20 Nov 2015.
Related trials for Immune Deficiency
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingPhase 2/3
Phase 2 and 3 Placebo Controlled & Long-term Extension Study of Rilzabrutinib in Adults With iCVID to Evaluate Efficacy, Safety, and Tolerability
Immunodeficiency Common Variable
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
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.
JACQUES REYNES, PU PH principal investigator
Univerty Hospital Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Immune Deficiency and HIV-related Gut Disease - Cause Unknown, run by University Hospital, Montpellier 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 9 inclusion and 9 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 20 Nov 2015. 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?
Infection of novo persistent (time frame: Infection of novo persistent the day of 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 20 Nov 2015.