Immune Reconstitution Inflammatory SyndromeNCT00286767
Immune Reconstitution Syndrome in HIV-Infected Patients Taking Antiretroviral Therapy
An observational study of Immune Reconstitution Inflammatory Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 countries.
Trial summary
This study will investigate what factors may lead to the development of immune reconstitution syndrome (IRIS) in HIV-infected patients and what the outcome is after IRIS. It will also seek to better define and describe the syndrome. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Immune Reconstitution Inflammatory Syndrome
- How many people
- 525 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Feb 2006to 1 Nov 2018
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the National Institutes of Health (NIH)/US site: HIV-1 infection, as documented by OraQuick rapid test using venipuncture whole blood, or fingerstick whole blood done at screening; or by reactive enzyme-linked immunosorbent assay (ELISA) and Western Blot as determined by NIH Clinical Pathology Laboratory or Leidos Biomedical Research, Inc. Monitoring Laboratory. HIV infection as determined by an outside Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory facility" will be accepted for enrollment and verified by a standard HIV-1 ELISA with Western Blot at NIH.
- For Keny Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP CRC)/Kenya site: HIV-1 infection will initially be diagnosed based upon two, serial rapid HIV tests according to Kenya Ministry of Health (MOH) guidelines. Volunteers entering this study will have HIV infection confirmed by two serial rapid HIV test in accordance with Kenya MOH guidelines and testing algorithm followed by a confirmation with a Western Blot using FDA approved-kits. Samples from participants with discrepant results (between the results from other institution and KEMRI/WRP-CRC laboratory) and/or indeterminate/negative Western Blot will be subjected to a nucleic acid assay i.e. DNA or RNA PCR. For Thailand, HIV-1 screening and confirmatory testing will be based on 3, HIV tests according to the Thai Ministry of Public Health guidelines. The subjects will initially be tested with a chemiluminescent microparticle immunoassay (CMIA) method that detects both HIV antigen and antibody. Confirmatory testing of HIV reactive samples by two different antibody detection methods will follow. Positive results by all three methods confirm HIV diagnosis. Discrepancy between the tests will require a nucleic acid detection method to confirm HIV diagnosis.
- No previous treatment with potent combination anti-retroviral therapy (ART), defined as any protease inhibitor (PI)-based or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen, or even triple nucleoside reverse transcriptase inhibitors (NRTI)-based regimen, consisting of at least three antiretroviral drugs (including a boosted PI with NNRTI combination). Patients with limited use of ART (less than 12 weeks duration) more than 24 weeks before screening will be eligible for study participation.
- Screening CD4+ cell count less than or equal to 100 cells/mm(3). * Note: CD4 < 100 cells/microL from an outside or the site s laboratory within 8 weeks prior to screening can be accepted as the screening value.
- Residence within the wider Washington D.C. area (approximately within a 120-mile radius from the NIH Bethesda campus) for the National Institutes of Health/US site and residents of the Kericho District Hospital catchment area, an approximate 93-mile (150 kilometers) radius, for the KEMRI/WRP CRC/Kenya site. Residence within the Bangkok Metropolitan area and nearby provinces are allowed to participate (approximately 120-mile radius from each of the clinical sites)
- Men and women age greater than or equal to 18 years.
Show all 10Show fewer
- Ability and willingness of subject or legal guardian/representative to understand study requirements and give informed consent.
- Be willing to allow storage of blood or tissue samples for future research. (For Thailand: storage of blood or tissue samples is an optional procedure and therefore not a inclusion criteria)
- Be willing to have HLA testing. (For Thailand: HLA testing is an optional procedure and therefore not an inclusion criteria)
- For the NIH/US site: Participants should have a primary care physician or will need to agree to find one during the first 24-48 weeks on study. For the KEMRI/WRP/Kenya site: Participants must be enrolled in the Kericho District Hospital HIV Clinic. For the two Thailand clinical sites: participants must be enrolled in the HIV clinic at either of the sites.
Who cannot join
- 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, diagnostic testing, and follow-up.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Thailand2 sites
The Thai Red Cross AID Research Center (TRC-ARC)
Bangkok, 10330
Bamrasnaradura Infectious Disease Institute (BIDI)
Nonthaburi, 11000
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Cohort Observational Study Evaluating Predictors, Incidence and Immunopathogenesis of Immune Reconstitution Syndrome (IRIS) in HIV-1 Infected Patients With CD4 Count Less Than or Equal to 100 Cells/microL Who Are Initiating Antiretroviral Therapy
This study will investigate what factors may lead to the development of immune reconstitution syndrome (IRIS) in HIV-infected patients and what the outcome is after IRIS. It will also seek to better define and describe the syndrome. IRIS is a condition that can occur in HIV-infected people following the start of antiretroviral therapy. The sudden improvement of immune function with this therapy can cause an unexpected worsening of diseases the patient already has, such as tuberculosis or fungal infections, and development of fever, enlarged lymph nodes or other complications, or even uncover a previously silent disease.
HIV-infected people who are at least 18 years old, whose CD4+T cell count is 100 cells per microliter or less, and who have not previously been treated with combination antiretroviral therapy or have taken the drugs for less than 3 months and more than 6 months before screening for this study may be eligible to participate. Candindates must also live within the wider DC area so that acute problems after therapy initiation will be evaluated at NIH. Candidates are evaluated before starting therapy with a medical history and physical examination, blood and urine tests, electrocardiogram, chest x-ray and CT scan of the chest, tuberculin skin testing, apheresis, and possibly an intestinal (gut) and lymph node biopsy (surgical removal of a small piece of tissue for microscopic examination). For apheresis, blood is collected through a needle in an arm vein and spun in a machine that separates the blood components. The white blood cells and plasma are removed, and the red cells and platelets are returned through the same needle or through a needle in a vein in the other arm.
Participants have a complete history and physical examination and additional blood tests, including genetic studies, upon entering the study. They start taking anti-HIV medications, prescribed according to the current standard of care, as well as medications to treat other infections, and treatment of IRIS, if needed. The study lasts about 4 years. Patients return to the clinic at 2, 4, 8 and 12 weeks after the entry visit, then every 12 weeks (about every 3 months) until week 48 (the first year), and then every 16 weeks (about every 4 months) until the end of the study. At most visits, patients have a medical history, physical examination and blood and urine tests, including CD4+T cell count and HIV plasma viral load measurement. Apheresis is also done at weeks 24 and 48 and then once every 48 weeks. Intestinal and lymph node biopsies (optional) are also done at weeks 24 and 48. A syphilis test and PAP smear (for women) are done yearly. and plasma, cells and serum are stored at almost every visit for immunologic studies.
Read the detailed description
A cohort observational study evaluating the predictors, incidence, clinical presentation and immunopathogenesis of Immune Reconstitution Syndrome (IRIS) in human immunodeficiency virus (HIV-1) infected patients with CD4 Count less than or equal to 100 cells/microL who are initiating antiretroviral therapy.
Immune reconstitution syndrome (IRIS) is a clinical syndrome that has been described in HIV infected patients after initiation of highly active anti-retroviral therapy (HAART), and is characterized by paradoxical acute worsening of an underlying opportunistic infection or AIDS-defining illness. There is no widely accepted syndromic definition, the pathogenesis of the syndrome is unclear and there is no specific therapy. The syndrome is more common in patients with low CD4+ T cell counts (less than 50 cells/microL) and in those with certain underlying infections (e.g. mycobacterial or cryptococcal infection) and is typically observed when there is evidence of response to HAART and while patients are still at risk for other opportunistic infections (OIs) or AIDS defining illnesses (e.g. pneumocystis jirovecii pneumonia or cytomegalovirus [CMV] retinitis). The incidence of IRIS varies depending on the studied population and is very frequent in developing countries creating significant diagnostic and therapeutic challenges as well as utilization of limited health resources.
DESIGN: International observational cohort study. Participants will be evaluated at baseline and followed according to the protocol follow up schedule after initiation of antiretroviral therapy for a total of two years. Acute symptoms that may be representing manifestations of IRIS will also be evaluated at additional acute care visits if necessary.
DURATION: Enrollment is ongoing. Each volunteer will be followed for at least two years. Total duration of the study will be approximately 8 years (including the optional extension phase in US).
SAMPLE SIZE: Approximately 600 patients will be enrolled, 200 in Kenya, 100 in Thailand and 300 in US. (enrollment is US will continue until approximately the other sites are full). Based on the incidence of IRIS in patients with low CD4 counts (approximately 20-40 percent), we anticipate strong power (approximately 90 percent) to identify baseline factors predictive of IRIS.
POPULATION: HIV-l-infected men and women, age greater than or equal to 18 years, antiretroviral therapy (ART)-naive with CD4+ T cell counts less than or equal to 100 cells/mm(3). Participants will be recruited and followed at three sites: the broader Washington DC, Kericho, Kenya and Bangkok, Thailand areas.
REGIMEN: Participants will be initiated on ART according to the clinical standard of care. If an OI or other AIDS defining illness is identified prior to or during screening or at any point during the study, they will also be treated according to standard of care.
- Keywords
- Opportunistic Infections, Immune Restoration Disease, Mycobacterial Infections, HIV-1 Infection, HIV, ART Naive
- Medical subject headings
- Immune Reconstitution Inflammatory Syndrome, Opportunistic Infections, Mycobacterium Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify baseline predictors of IRIS within 6 months of HAART initiation prospectively in a group of HIV-1 infected patients with advanced disease who are starting antiretroviral therapy.
Measured: During the data analysis phase at the end of the study
To evaluate the immunopathogenesis of IRIS with the goal to identify more appropriate targets for future therapeutic interventions.
Measured: During the data analysis phase at the end of the study
Secondary outcomes (3)
Evaluate the baseline clinical and immunological characteristics ofindividuals who develop IRIS and compare them with those who do not.
Measured: During the data analysis phase at the end of the study
To study the incidence and clinical manifestations of IRIS prospectively in a group of HIV-1 infected patients with advanced disease who are initiating antiretroviral therapy.
Measured: During the data analysis phase at the end of the study
To evaluate the impact of IRIS on the risk of subsequent death (attributable mortality).
Measured: During the data analysis phase at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study start1 Feb 2006
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- 525 participants (actual)
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
- NCT00286767
- Sponsor's protocol ID
- 060086
- Other IDs
- 06-I-0086
- Status last verified
- 1 Nov 2018
- First submitted
- 3 Feb 2006
- Last updated
- 7 Oct 2019
- Results posted
- No
Publications
French MA, Price P, Stone SF. Immune restoration disease after antiretroviral therapy. AIDS. 2004 Aug 20;18(12):1615-27. doi: 10.1097/01.aids.0000131375.21070.06.
PubMed 15280772French MA. Antiretroviral therapy. Immune restoration disease in HIV-infected patients on HAART. AIDS Read. 1999 Nov;9(8):548-9, 554-5, 559-62.
PubMed 11082733Shelburne SA, Visnegarwala F, Darcourt J, Graviss EA, Giordano TP, White AC Jr, Hamill RJ. Incidence and risk factors for immune reconstitution inflammatory syndrome during highly active antiretroviral therapy. AIDS. 2005 Mar 4;19(4):399-406. doi: 10.1097/01.aids.0000161769.06158.8a.
PubMed 15750393Rocco 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 37040388Vinhaes CL, Sheikh V, Oliveira-de-Souza D, Wang J, Rupert A, Roby G, Arriaga MB, Fukutani KF, Sawe F, Shaffer D, Ananworanich J, Phanuphak N, Andrade BB, Sereti I. An Inflammatory Composite Score Predicts Mycobacterial Immune Reconstitution Inflammatory Syndrome in People with Advanced HIV: A Prospective International Cohort Study. J Infect Dis. 2021 Apr 8;223(7):1275-1283. doi: 10.1093/infdis/jiaa484.
PubMed 32761193Gouel-Cheron A, Nason M, Rupert A, Sheikh V, Robby G, Fahle GA, Sereti I. Cardiovascular Biomarker Profile on Antiretroviral Therapy Is Not Influenced by History of an IRIS Event in People With HIV and Suppressed Viremia. Open Forum Infect Dis. 2020 Jan 11;7(1):ofaa017. doi: 10.1093/ofid/ofaa017. eCollection 2020 Jan.
PubMed 32016127Mahnke YD, Greenwald JH, DerSimonian R, Roby G, Antonelli LR, Sher A, Roederer M, Sereti I. Selective expansion of polyfunctional pathogen-specific CD4(+) T cells in HIV-1-infected patients with immune reconstitution inflammatory syndrome. Blood. 2012 Mar 29;119(13):3105-12. doi: 10.1182/blood-2011-09-380840. Epub 2012 Jan 4.
PubMed 22219223Antonelli LR, Mahnke Y, Hodge JN, Porter BO, Barber DL, DerSimonian R, Greenwald JH, Roby G, Mican J, Sher A, Roederer M, Sereti I. Elevated frequencies of highly activated CD4+ T cells in HIV+ patients developing immune reconstitution inflammatory syndrome. Blood. 2010 Nov 11;116(19):3818-27. doi: 10.1182/blood-2010-05-285080. Epub 2010 Jul 26.
PubMed 20660788
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Observational Study Evaluating Predictors, Incidence and Immunopathogenesis of Immune Reconstitution Syndrome (IRIS) in HIV-1 Infected Patients With CD4 Count Less Than or Equal to 100 Cells/microL Who Are Initiating Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00286767
- Acronym / sponsor ID
- 060086
- Keywords
- Opportunistic Infections, Immune Restoration Disease, Mycobacterial Infections, HIV-1 Infection, HIV, ART Naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 1 Feb 2006
- Study completion
- 1 Nov 2018
- First posted
- 3 Feb 2006 (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 will investigate what factors may lead to the development of immune reconstitution syndrome (IRIS) in HIV-infected patients and what the outcome is after IRIS. It will also seek to better define and describe the syndrome. IRIS is a condition that can occur in HIV-infected people following the start of antiretroviral therapy. The sudden improvement of immune function with this therapy can cause an unexpected worsening of diseases the patient already has, such as tuberculosis or fungal infections, and development of fever, enlarged lymph nodes or other complications, or even uncover a previously silent disease.
HIV-infected people who are at least 18 years old, whose CD4+T cell count is 100 cells per microliter or less, and who have not previously been treated with combination antiretroviral therapy or have taken the drugs for less than 3 months and more than 6 months before screening for this study may be eligible to participate. Candindates must also live within the wider DC area so that acute problems after therapy initiation will be evaluated at NIH. Candidates are evaluated before starting therapy with a medical history and physical examination, blood and urine tests, electrocardiogram, chest x-ray and CT scan of the chest, tuberculin skin testing, apheresis, and possibly an intestinal (gut) and lymph node biopsy (surgical removal of a small piece of tissue for microscopic examination). For apheresis, blood is collected through a needle in an arm vein and spun in a machine that separates the blood components. The white blood cells and plasma are removed, and the red cells and platelets are returned through the same needle or through a needle in a vein in the other arm.
Participants have a complete history and physical examination and additional blood tests, including genetic studies, upon entering the study. They start taking anti-HIV medications, prescribed according to the current standard of care, as well as medications to treat other infections, and treatment of IRIS, if needed. The study lasts about 4 years. Patients return to the clinic at 2, 4, 8 and 12 weeks after the entry visit, then every 12 weeks (about every 3 months) until week 48 (the first year), and then every 16 weeks (about every 4 months) until the end of the study. At most visits, patients have a medical history, physical examination and blood and urine tests, including CD4+T cell count and HIV plasma viral load measurement. Apheresis is also done at weeks 24 and 48 and then once every 48 weeks. Intestinal and lymph node biopsies (optional) are also done at weeks 24 and 48. A syphilis test and PAP smear (for women) are done yearly. and plasma, cells and serum are stored at almost every visit for immunologic studies.
Detailed description
A cohort observational study evaluating the predictors, incidence, clinical presentation and immunopathogenesis of Immune Reconstitution Syndrome (IRIS) in human immunodeficiency virus (HIV-1) infected patients with CD4 Count less than or equal to 100 cells/microL who are initiating antiretroviral therapy.
Immune reconstitution syndrome (IRIS) is a clinical syndrome that has been described in HIV infected patients after initiation of highly active anti-retroviral therapy (HAART), and is characterized by paradoxical acute worsening of an underlying opportunistic infection or AIDS-defining illness. There is no widely accepted syndromic definition, the pathogenesis of the syndrome is unclear and there is no specific therapy. The syndrome is more common in patients with low CD4+ T cell counts (less than 50 cells/microL) and in those with certain underlying infections (e.g. mycobacterial or cryptococcal infection) and is typically observed when there is evidence of response to HAART and while patients are still at risk for other opportunistic infections (OIs) or AIDS defining illnesses (e.g. pneumocystis jirovecii pneumonia or cytomegalovirus [CMV] retinitis). The incidence of IRIS varies depending on the studied population and is very frequent in developing countries creating significant diagnostic and therapeutic challenges as well as utilization of limited health resources.
DESIGN: International observational cohort study. Participants will be evaluated at baseline and followed according to the protocol follow up schedule after initiation of antiretroviral therapy for a total of two years. Acute symptoms that may be representing manifestations of IRIS will also be evaluated at additional acute care visits if necessary.
DURATION: Enrollment is ongoing. Each volunteer will be followed for at least two years. Total duration of the study will be approximately 8 years (including the optional extension phase in US).
SAMPLE SIZE: Approximately 600 patients will be enrolled, 200 in Kenya, 100 in Thailand and 300 in US. (enrollment is US will continue until approximately the other sites are full). Based on the incidence of IRIS in patients with low CD4 counts (approximately 20-40 percent), we anticipate strong power (approximately 90 percent) to identify baseline factors predictive of IRIS.
POPULATION: HIV-l-infected men and women, age greater than or equal to 18 years, antiretroviral therapy (ART)-naive with CD4+ T cell counts less than or equal to 100 cells/mm(3). Participants will be recruited and followed at three sites: the broader Washington DC, Kericho, Kenya and Bangkok, Thailand areas.
REGIMEN: Participants will be initiated on ART according to the clinical standard of care. If an OI or other AIDS defining illness is identified prior to or during screening or at any point during the study, they will also be treated according to standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For Keny Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP CRC)/Kenya site: HIV-1 infection will initially be diagnosed based upon two, serial rapid HIV tests according to Kenya Ministry of Health (MOH) guidelines. Volunteers entering this study will have HIV infection confirmed by two serial rapid HIV test in accordance with Kenya MOH guidelines and testing algorithm followed by a confirmation with a Western Blot using FDA approved-kits. Samples from participants with discrepant results (between the results from other institution and KEMRI/WRP-CRC laboratory) and/or indeterminate/negative Western Blot will be subjected to a nucleic acid assay i.e. DNA or RNA PCR. For Thailand, HIV-1 screening and confirmatory testing will be based on 3, HIV tests according to the Thai Ministry of Public Health guidelines. The subjects will initially be tested with a chemiluminescent microparticle immunoassay (CMIA) method that detects both HIV antigen and antibody. Confirmatory testing of HIV reactive samples by two different antibody detection methods will follow. Positive results by all three methods confirm HIV diagnosis. Discrepancy between the tests will require a nucleic acid detection method to confirm HIV diagnosis.
Key exclusion criteria (2 listed)
- 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, diagnostic testing, and follow-up.
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
To identify baseline predictors of IRIS within 6 months of HAART initiation prospectively in a group of HIV-1 infected patients with advanced disease who are starting antiretroviral therapy.
Time frame: During the data analysis phase at the end of the study
To evaluate the immunopathogenesis of IRIS with the goal to identify more appropriate targets for future therapeutic interventions.
Time frame: During the data analysis phase at the end of the study
3 secondary outcomes
Evaluate the baseline clinical and immunological characteristics ofindividuals who develop IRIS and compare them with those who do not.
Time frame: During the data analysis phase at the end of the study
To study the incidence and clinical manifestations of IRIS prospectively in a group of HIV-1 infected patients with advanced disease who are initiating antiretroviral therapy.
Time frame: During the data analysis phase at the end of the study
To evaluate the impact of IRIS on the risk of subsequent death (attributable mortality).
Time frame: During the data analysis phase at the end of the study
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 7 Oct 2019.
- Background: PubMed 15280772French MA, Price P, Stone SF. Immune restoration disease after antiretroviral therapy. AIDS. 2004 Aug 20;18(12):1615-27. doi: 10.1097/01.aids.0000131375.21070.06.
- Background: PubMed 11082733French MA. Antiretroviral therapy. Immune restoration disease in HIV-infected patients on HAART. AIDS Read. 1999 Nov;9(8):548-9, 554-5, 559-62.
- Background: PubMed 15750393Shelburne SA, Visnegarwala F, Darcourt J, Graviss EA, Giordano TP, White AC Jr, Hamill RJ. Incidence and risk factors for immune reconstitution inflammatory syndrome during highly active antiretroviral therapy. AIDS. 2005 Mar 4;19(4):399-406. doi: 10.1097/01.aids.0000161769.06158.8a.
- 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 32761193Vinhaes CL, Sheikh V, Oliveira-de-Souza D, Wang J, Rupert A, Roby G, Arriaga MB, Fukutani KF, Sawe F, Shaffer D, Ananworanich J, Phanuphak N, Andrade BB, Sereti I. An Inflammatory Composite Score Predicts Mycobacterial Immune Reconstitution Inflammatory Syndrome in People with Advanced HIV: A Prospective International Cohort Study. J Infect Dis. 2021 Apr 8;223(7):1275-1283. doi: 10.1093/infdis/jiaa484.
- Derived from this study: PubMed 32016127Gouel-Cheron A, Nason M, Rupert A, Sheikh V, Robby G, Fahle GA, Sereti I. Cardiovascular Biomarker Profile on Antiretroviral Therapy Is Not Influenced by History of an IRIS Event in People With HIV and Suppressed Viremia. Open Forum Infect Dis. 2020 Jan 11;7(1):ofaa017. doi: 10.1093/ofid/ofaa017. eCollection 2020 Jan.
- Derived from this study: PubMed 22219223Mahnke YD, Greenwald JH, DerSimonian R, Roby G, Antonelli LR, Sher A, Roederer M, Sereti I. Selective expansion of polyfunctional pathogen-specific CD4(+) T cells in HIV-1-infected patients with immune reconstitution inflammatory syndrome. Blood. 2012 Mar 29;119(13):3105-12. doi: 10.1182/blood-2011-09-380840. Epub 2012 Jan 4.
- Derived from this study: PubMed 20660788Antonelli LR, Mahnke Y, Hodge JN, Porter BO, Barber DL, DerSimonian R, Greenwald JH, Roby G, Mican J, Sher A, Roederer M, Sereti I. Elevated frequencies of highly activated CD4+ T cells in HIV+ patients developing immune reconstitution inflammatory syndrome. Blood. 2010 Nov 11;116(19):3818-27. doi: 10.1182/blood-2010-05-285080. Epub 2010 Jul 26.
Related trials for Immune Reconstitution Inflammatory Syndrome
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
RecruitingObservational study
PET Imaging and Lymph Node Assessment of IRIS in People With AIDS
Immune Reconstitution Inflammatory Syndrome
Not yet recruitingObservational study
MBLA to Differentiate IRIS From Treatment Failure in Extrapulmonary Tuberculosis
Extrapulmonary Tuberculosis
Not yet recruitingPhase 2
NAI for Sepsis With Persistent Lymphopenia
Sepsis, Septic Shock
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.
Irini Sereti, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
3 sites in 2 countries: 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 3 sites in 2 countries.
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 10 inclusion and 2 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 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand, 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?
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?
To identify baseline predictors of IRIS within 6 months of HAART initiation prospectively in a group of HIV-1 infected patients with advanced disease who are starting antiretroviral therapy. (time frame: During the data analysis phase at the end of the study). 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?
On the ClinicalTrials.gov record for NCT00286767, which also lists 9 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 7 Oct 2019.