Immune Reconstitution Inflammatory SyndromeNCT02147405
PET Imaging and Lymph Node Assessment of IRIS in People With AIDS
An observational study of Immune Reconstitution Inflammatory Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Sometimes people with HIV, the virus that causes AIDS, can have new or worsening symptoms soon after starting HIV medications. Often these symptoms are caused by immune reconstitution inflammatory syndrome (IRIS). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Immune Reconstitution Inflammatory Syndrome
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2014to 30 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: random sample of participants.
- ELIGIBILITY CRITERIA:
ART NAIVE ARM INCLUSION CRITERIA:
- Documentation of HIV-1 infection. Results from outside facilities will be accepted for enrollment.
- No recent (within the past two years) treatment with combination anti-retroviral therapy (ART). Patients with limited (no more than 2-3 weeks) recent use of potent combination ART may be eligible for study participation if, the opinion of the investigator, the ART usage will not impact the scientific validity of the protocol
- Documented CD4+ cell count <=100 cells/mm^3 within the past 8 weeks.
- Residence within the wider Washington D.C. area (within a 100-mile radius from the NIH Bethesda campus) and plans to stay in the area for 48 weeks
- Men or women age >=18 years.
- Ability and willingness of subject (or legal guardian/representative) to understand study requirements and give informed consent*.
- Willingness to allow storage of blood or tissue samples for future research
- Willingness at time of screening to undergo study procedures (phlebotomy, apheresis, optional FDG-PET/CT and lymph node biopsy)
- Willingness to have genetic testing
- Participants should have a primary care physician or will need to agree to have one established by 24 weeks on study.
- Potential participants who lack decision-making capacity to consent to research participation may enroll in this study at the discretion of the investigator if this incapacity is expected to last for a short period of time.
IRIS ARM INCLUSION CRITERIA:
- Documentation of HIV-1 infection. Results from outside facilities will be accepted for enrollment.
- Meet criteria suspicious for IRIS (Must meet 4/5 following criteria):
- Initiation (reintroduction or change) in antiretroviral therapy/regimen
- Evidence of:
- an increase in CD4+ cell count defined as >= 50cell/mm^3 or a >= 2 fold rise in CD4+ cell count, and/or ii. decrease in the HIV-1 viral load of >=0.5 log10
- Symptoms and/or signs consistent with an infectious/inflammatory condition.
- These symptoms and/or signs cannot be explained by a newly acquired infection, the expected clinical course of a previously recognized infectious agent, or the side effects of antiretroviral therapy itself.
- The infectious/inflammatory condition must be attributable to a specific pathogen or condition. Criteria d or e may not be met for suspected IRIS definition.
- Residence within the wider Washington D.C. area (within a 100-mile radius from the NIH Bethesda campus) **Participants from outside of the 100 mile radius may be enrolled on a case by case basis to diagnose or manage IRIS.
- Men or women age >=18 years.
- Ability and willingness of subject to understand study requirements and give informed consent*.
- Willingness to allow storage of blood or tissue samples for future research
- Willingness at time of screening to undergo study procedures (phlebotomy, apheresis, an optional FDG-PET/CT, and lymph node biopsy)
- Willingness to have genetic testing
- Participants should have a primary care physician who will initiate the referral.
- Potential participants who lack decision-making capacity to consent to research participation may enroll in this study at the discretion of the investigator if this incapacity is expected to last for a short period of time.
SUBJECT EXCLUSION CRITERIA:
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Pregnancy will be an exclusion criterion for study entry given the intense nature of the protocol regarding blood draws, apheresis, biopsies and FDG-PET/CT imaging.
- Inadequate venous access for phlebotomy and apheresis procedures as assessed by the study team.
- Women who are breastfeeding.
- A life-threatening underlying illness that according to the study team requires immediate intervention such as PML requiring initiation of ARVs or lymphomas requiring chemotherapy initiation.
- An inability to consent that is estimated by the study team to be irreversible.
- History of significant medical non-adherence which would, in the opinion of the investigator, interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: PET Imaging and Lymph Node Assessment of IRIS in Persons With AIDS
Background:
- Sometimes people with HIV, the virus that causes AIDS, can have new or worsening symptoms soon after starting HIV medications. Often these symptoms are caused by immune reconstitution inflammatory syndrome (IRIS). Researchers want to study why and how people develop IRIS and how best to prevent and treat it.
Read more
Objectives:
- To learn the causes and effects of IRIS, and how to best manage it.
Eligibility:
- Adults 18 and older with HIV and low CD4 counts,, about to start HIV medicines; or those already taking HIV medicines with symptoms thought to be related to IRIS.
Design:
- Participants not on ART will have screening blood tests for CD4 count, HIV viral load and genetic testing.
- After the screening blood tests and before starting HIV medicines., participants will return for more than 1 visit for the following:
- review of medical history<TAB>
- physical and eye exams
- blood, urine, and tuberculosis (TB) tests
- electrocardiogram (EKG)
- chest x-ray
- apheresis: a blood drawing procedure where blood is removed from a vein, white blood cells are separated and collected, and the rest of the blood is returned to the person using another vein
- - PET scan - a procedure where a small amount of radioactive material is injected in a vein. The participant then lies on a table that slides into a scanner which takes images of the body.
- lymph node biopsy
- stool collection by swab
- After completion of the above, HIV medicines will be started.
- Follow-up visits will be at 2, 4, 8, and 12 weeks after starting ART, then every 12 weeks. Some of the tests above may be repeated.
- Participants already on HIV medicines who may have IRIS will be screened over a 4 week time period to see if they really are experiencing IRIS. The screening process will include all of the items listed above. Follow-up visits will be at Weeks, 4, 8, 12 and then every 12 weeks.
- The study will last 1 year for both groups but may be extended to 2 years (3 additional appointments) for some participants....
Read the detailed description
Immune reconstitution inflammatory syndrome (IRIS) in HIV infection represents a paradoxical, frequently inflammatory, immune response after initiation of antiretroviral (ART) therapy. The immunopathogenesis of IRIS remains elusive partially due to a lack of tissue sampling and a lack of detailed screening, including imaging, for subclinical opportunistic infections in many studies. Most pathogenesis studies to date have been performed in peripheral blood with a few notable exceptions of cryptococcal IRIS studies in which cerebrospinal fluid (CSF) samples were obtained and evaluated.
This is a 2-arm natural history study intended to evaluate the incidence, predictors and pathogenic mechanisms of IRIS in HIV-1 infected adults (age >18 years). An ART naive arm will enroll 140 patients who are ART-na(SqrRoot) ve with CD4+ T cell counts <100 cells/mm^3. These participants will initiate ART according to the clinical standard of care. Any opportunistic infections (OIs) or AIDS-defining illnesses identified prior to, during screening or at any point during the study, will also be treated according to standard of care. The IRIS arm will enroll 60 participants who are ART-treated and meet criteria suspicious for IRIS, with any CD4+ T cell count. The ART naive arm will be followed for 48 weeks, with an optional extension up to week 96. The IRIS arm will be followed for 48 weeks after enrollment if the IRIS event is confirmed, also with an optional extension up to week 96. In both arms, subjects must have adequate venous access and will undergo collection of whole blood by phlebotomy, leukapheresis, lymph node biopsy, and fluorodeoxyglucose-positron emission tomography (FDG-PET/CT) at designated study visits.
- Keywords
- FDG PET/CT Scan, Lymph Node Biopsy, Apheresis, Natural History
- Medical subject headings
- Immune Reconstitution Inflammatory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ARV naive | Patients that have not started or have ever been on ARV therapy. | |
| IRIS | Patients that are on medication but are possibly experiencing an IRIS event. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate LN inflammation (by FDG-PET)
Correlate LN inflammation (by FDG-PET) and degree of fibrosis as assessed by immunohistochemistry (IHC) with development of IRIS and degree if immune reconstitution after 1 year of ART
Measured: After completion of enrollment of all participants.
Pathogenesis studies
Pathogenesis studies to evaluate role of myeloid cells in periphery and LN in IRIS
Measured: After completion of enrollment of all participants.
FDG-PET scans
FDG-PET measurements and correlations with viremia, biomarkers, OI, immune recovery of B cells and Tfh cells with ART
Measured: After completion of enrollment of all participants.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study start30 May 2014
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Immune Reconstitution Inflammatory SyndromeStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Irini Sereti, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147405
- Sponsor's protocol ID
- 140124
- Other IDs
- 14-I-0124
- Status last verified
- 20 Aug 2026
- First submitted
- 22 May 2014
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make IPD available at this time.
Publications
Naidoo K, Yende-Zuma N, Padayatchi N, Naidoo K, Jithoo N, Nair G, Bamber S, Gengiah S, El-Sadr WM, Friedland G, Abdool Karim S. The immune reconstitution inflammatory syndrome after antiretroviral therapy initiation in patients with tuberculosis: findings from the SAPiT trial. Ann Intern Med. 2012 Sep 4;157(5):313-24. doi: 10.7326/0003-4819-157-5-201209040-00004.
PubMed 22944873Barber DL, Andrade BB, Sereti I, Sher A. Immune reconstitution inflammatory syndrome: the trouble with immunity when you had none. Nat Rev Microbiol. 2012 Jan 9;10(2):150-6. doi: 10.1038/nrmicro2712.
PubMed 22230950Sereti I, Rodger AJ, French MA. Biomarkers in immune reconstitution inflammatory syndrome: signals from pathogenesis. Curr Opin HIV AIDS. 2010 Nov;5(6):504-10. doi: 10.1097/COH.0b013e32833ed774.
PubMed 20966640Lage SL, Ramaswami R, Rocco JM, Rupert A, Davis DA, Lurain K, Manion M, Whitby D, Yarchoan R, Sereti I. Inflammasome activation in patients with Kaposi sarcoma herpesvirus-associated diseases. Blood. 2024 Oct 3;144(14):1496-1507. doi: 10.1182/blood.2024024144.
PubMed 38941593Rocco JM, Zhou Y, Liu NS, Laidlaw E, Galindo F, Anderson MV, Rupert A, Lage SL, Ortega-Villa AM, Yu S, Lisco A, Manion M, Vassiliou GS, Dunbar CE, Sereti I. Clonal hematopoiesis in people with advanced HIV and associated inflammatory syndromes. JCI Insight. 2024 Apr 2;9(9):e174783. doi: 10.1172/jci.insight.174783.
PubMed 38564303Rocco JM, Laidlaw E, Galindo F, Anderson M, Sortino O, Kuriakose S, Lisco A, Manion M, Sereti I. Mycobacterial Immune Reconstitution Inflammatory Syndrome in HIV is Associated With Protein-Altering Variants in Hemophagocytic Lymphohistiocytosis-Related Genes. J Infect Dis. 2023 Jul 14;228(2):111-115. doi: 10.1093/infdis/jiad059.
PubMed 37040388Manion M, Dulanto Chiang A, Pei L, Wong CS, Khil P, Hammoud DA, Anderson M, Laidlaw E, Kuriakose S, Lisco A; NISC Comparative Sequencing Program; Zelazny AM, Dekker JP, Sereti I. Disseminated Mycobacterium marinum in Human Immunodeficiency Virus Unmasked by Immune Reconstitution Inflammatory Syndrome. J Infect Dis. 2021 Aug 2;224(3):453-457. doi: 10.1093/infdis/jiaa769.
PubMed 33336253Hammoud DA, Boulougoura A, Papadakis GZ, Wang J, Dodd LE, Rupert A, Higgins J, Roby G, Metzger D, Laidlaw E, Mican JM, Pau A, Lage S, Wong CS, Lisco A, Manion M, Sheikh V, Millo C, Sereti I. Increased Metabolic Activity on 18F-Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography in Human Immunodeficiency Virus-Associated Immune Reconstitution Inflammatory Syndrome. Clin Infect Dis. 2019 Jan 7;68(2):229-238. doi: 10.1093/cid/ciy454.
PubMed 30215671
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging and Lymph Node Assessment of IRIS in Persons With AIDS
- ClinicalTrials.gov ID
- NCT02147405
- Acronym / sponsor ID
- 140124
- Keywords
- FDG PET/CT Scan, Lymph Node Biopsy, Apheresis, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 30 May 2014 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 26 May 2014 (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.
Background:
- Sometimes people with HIV, the virus that causes AIDS, can have new or worsening symptoms soon after starting HIV medications. Often these symptoms are caused by immune reconstitution inflammatory syndrome (IRIS). Researchers want to study why and how people develop IRIS and how best to prevent and treat it.
Objectives:
- To learn the causes and effects of IRIS, and how to best manage it.
Eligibility:
- Adults 18 and older with HIV and low CD4 counts,, about to start HIV medicines; or those already taking HIV medicines with symptoms thought to be related to IRIS.
Design:
- Participants not on ART will have screening blood tests for CD4 count, HIV viral load and genetic testing.
- After the screening blood tests and before starting HIV medicines., participants will return for more than 1 visit for the following:
- review of medical history<TAB>
- physical and eye exams
- blood, urine, and tuberculosis (TB) tests
- electrocardiogram (EKG)
- chest x-ray
- apheresis: a blood drawing procedure where blood is removed from a vein, white blood cells are separated and collected, and the rest of the blood is returned to the person using another vein
- - PET scan - a procedure where a small amount of radioactive material is injected in a vein. The participant then lies on a table that slides into a scanner which takes images of the body.
- lymph node biopsy
- stool collection by swab
- After completion of the above, HIV medicines will be started.
- Follow-up visits will be at 2, 4, 8, and 12 weeks after starting ART, then every 12 weeks. Some of the tests above may be repeated.
- Participants already on HIV medicines who may have IRIS will be screened over a 4 week time period to see if they really are experiencing IRIS. The screening process will include all of the items listed above. Follow-up visits will be at Weeks, 4, 8, 12 and then every 12 weeks.
- The study will last 1 year for both groups but may be extended to 2 years (3 additional appointments) for some participants....
Detailed description
Immune reconstitution inflammatory syndrome (IRIS) in HIV infection represents a paradoxical, frequently inflammatory, immune response after initiation of antiretroviral (ART) therapy. The immunopathogenesis of IRIS remains elusive partially due to a lack of tissue sampling and a lack of detailed screening, including imaging, for subclinical opportunistic infections in many studies. Most pathogenesis studies to date have been performed in peripheral blood with a few notable exceptions of cryptococcal IRIS studies in which cerebrospinal fluid (CSF) samples were obtained and evaluated.
This is a 2-arm natural history study intended to evaluate the incidence, predictors and pathogenic mechanisms of IRIS in HIV-1 infected adults (age >18 years). An ART naive arm will enroll 140 patients who are ART-na(SqrRoot) ve with CD4+ T cell counts <100 cells/mm^3. These participants will initiate ART according to the clinical standard of care. Any opportunistic infections (OIs) or AIDS-defining illnesses identified prior to, during screening or at any point during the study, will also be treated according to standard of care. The IRIS arm will enroll 60 participants who are ART-treated and meet criteria suspicious for IRIS, with any CD4+ T cell count. The ART naive arm will be followed for 48 weeks, with an optional extension up to week 96. The IRIS arm will be followed for 48 weeks after enrollment if the IRIS event is confirmed, also with an optional extension up to week 96. In both arms, subjects must have adequate venous access and will undergo collection of whole blood by phlebotomy, leukapheresis, lymph node biopsy, and fluorodeoxyglucose-positron emission tomography (FDG-PET/CT) at designated study visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARV naive | – | –Patients that have not started or have ever been on ARV therapy. |
| IRIS | – | –Patients that are on medication but are possibly experiencing an IRIS event. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- random sample of participants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlate LN inflammation (by FDG-PET)
Time frame: After completion of enrollment of all participants.
Correlate LN inflammation (by FDG-PET) and degree of fibrosis as assessed by immunohistochemistry (IHC) with development of IRIS and degree if immune reconstitution after 1 year of ART
Pathogenesis studies
Time frame: After completion of enrollment of all participants.
Pathogenesis studies to evaluate role of myeloid cells in periphery and LN in IRIS
FDG-PET scans
Time frame: After completion of enrollment of all participants.
FDG-PET measurements and correlations with viremia, biomarkers, OI, immune recovery of B cells and Tfh cells with ART
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 22944873Naidoo K, Yende-Zuma N, Padayatchi N, Naidoo K, Jithoo N, Nair G, Bamber S, Gengiah S, El-Sadr WM, Friedland G, Abdool Karim S. The immune reconstitution inflammatory syndrome after antiretroviral therapy initiation in patients with tuberculosis: findings from the SAPiT trial. Ann Intern Med. 2012 Sep 4;157(5):313-24. doi: 10.7326/0003-4819-157-5-201209040-00004.
- Background: PubMed 22230950Barber DL, Andrade BB, Sereti I, Sher A. Immune reconstitution inflammatory syndrome: the trouble with immunity when you had none. Nat Rev Microbiol. 2012 Jan 9;10(2):150-6. doi: 10.1038/nrmicro2712.
- Background: PubMed 20966640Sereti I, Rodger AJ, French MA. Biomarkers in immune reconstitution inflammatory syndrome: signals from pathogenesis. Curr Opin HIV AIDS. 2010 Nov;5(6):504-10. doi: 10.1097/COH.0b013e32833ed774.
- Derived from this study: PubMed 38941593Lage SL, Ramaswami R, Rocco JM, Rupert A, Davis DA, Lurain K, Manion M, Whitby D, Yarchoan R, Sereti I. Inflammasome activation in patients with Kaposi sarcoma herpesvirus-associated diseases. Blood. 2024 Oct 3;144(14):1496-1507. doi: 10.1182/blood.2024024144.
- Derived from this study: PubMed 38564303Rocco JM, Zhou Y, Liu NS, Laidlaw E, Galindo F, Anderson MV, Rupert A, Lage SL, Ortega-Villa AM, Yu S, Lisco A, Manion M, Vassiliou GS, Dunbar CE, Sereti I. Clonal hematopoiesis in people with advanced HIV and associated inflammatory syndromes. JCI Insight. 2024 Apr 2;9(9):e174783. doi: 10.1172/jci.insight.174783.
- Derived from this study: PubMed 37040388Rocco JM, Laidlaw E, Galindo F, Anderson M, Sortino O, Kuriakose S, Lisco A, Manion M, Sereti I. Mycobacterial Immune Reconstitution Inflammatory Syndrome in HIV is Associated With Protein-Altering Variants in Hemophagocytic Lymphohistiocytosis-Related Genes. J Infect Dis. 2023 Jul 14;228(2):111-115. doi: 10.1093/infdis/jiad059.
- Derived from this study: PubMed 33336253Manion M, Dulanto Chiang A, Pei L, Wong CS, Khil P, Hammoud DA, Anderson M, Laidlaw E, Kuriakose S, Lisco A; NISC Comparative Sequencing Program; Zelazny AM, Dekker JP, Sereti I. Disseminated Mycobacterium marinum in Human Immunodeficiency Virus Unmasked by Immune Reconstitution Inflammatory Syndrome. J Infect Dis. 2021 Aug 2;224(3):453-457. doi: 10.1093/infdis/jiaa769.
- Derived from this study: PubMed 30215671Hammoud DA, Boulougoura A, Papadakis GZ, Wang J, Dodd LE, Rupert A, Higgins J, Roby G, Metzger D, Laidlaw E, Mican JM, Pau A, Lage S, Wong CS, Lisco A, Manion M, Sheikh V, Millo C, Sereti I. Increased Metabolic Activity on 18F-Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography in Human Immunodeficiency Virus-Associated Immune Reconstitution Inflammatory Syndrome. Clin Infect Dis. 2019 Jan 7;68(2):229-238. doi: 10.1093/cid/ciy454.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to make IPD available at this time.
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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.
Irini Sereti, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 Immune Reconstitution Inflammatory Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irini Sereti, M.D. ((301) 496-5533, isereti@niaid.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate LN inflammation (by FDG-PET) (time frame: After completion of enrollment of all participants.). The study lists 3 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 NCT02147405, which also lists 8 linked publications.
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 Oct 2026.