[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kshv-inflammatory-cytokine-syndrome-kics\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kshv-inflammatory-cytokine-syndrome-kics":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100164892","phase-2-natural-history-study-of-the-kshv-inflammatory-cytokine-syndrome-kics-100164892",false,"NCT01419561","Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)","* INCLUSION CRITERIA:\n* Age greater than or equal to18 Years.\n* Any HIV status.\n* At least two manifestations drawn from at least two of the categories (clinical symptoms, laboratory abnormalities and\u002For radiographic abnormalities), which are at least possibly attributable to KICS and are not readily explicable from known medical conditions in the participant:\n* Clinical symptoms (each at least grade 1 by CTCAE definitions)\n* Fever (\\>38 degrees C), chills or rigors\n* Fatigue or lethargy\n* Cachexia or edema\n* Cough, dyspnea, airway hyperreactivity, or nasal inflammation\n* Nausea, anorexia, abdominal pain or altered bowel habit\n* Athralgia or myalgia\n* Altered mental state\n* Neuropathy with or without pain\n* Laboratory abnormalities\n* Anemia (hemoglobin\\\u003C12.0g\u002FdL)\n* Thrombocytopenia (platelets\\\u003C100,000 cells\u002FmicroL)\n* Leukopenia (white cell count\\\u003C4,000 cells\u002FmicroL)\n* Hypoalbuminemia (albumin\\\u003C3.5g\u002FdL)\n* Hyponatremia (sodium\\\u003C135mmol\u002FL)\n* Coagulopathy (PT or PTT \\>1.5 times upper limit of normal)\n* Radiographic abnormalities\n* Pathologic lymphadenopathy (at least five discrete nodes each \\>1cm in their longest dimension)\n* Splenomegaly (\\>12 cm in the longest dimension)\n* Hepatomegaly (\\>17cm in the longest dimension)\n* Body cavity effusions not caused by primary effusion lymphoma nor chylous effusions directly related to lymphatic infiltration by KS\n* C-reactive protein (CRP) \\>3mg\u002FL.\n* Exposure risk for KSHV infection (including being a first or second generation immigrant from an endemic area, or male-to-male sexual activity) or evidence of KSHV infection demonstrated by one of:\n\n  * Molecular evidence of KSHV in whole blood, or KSHV VL levels within circulating PBMCs as determined by the Whitby laboratory\n  * Immunohistochemical evidence of KSHV in tissues (for example by staining for LANA or vIL-6) confirmed in the Laboratory of Pathology (LP), CCR, NCI.\n  * Presence of KS or PEL (KSHV-associated malignancies), confirmed in the LP, CCR, NCI.\n* Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and after treatment (if received), according to drug requirements. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\nEXCLUSION CRITERIA:\n\n\\- Biopsy proven KSHV-associated MCD, confirmed in the LP, CCR, NCI.\n\nNote: In collaboration with LP, we have recently found that some participants with KICS but without a lymph node or splenic diagnosis of MCD have MCD-like cells in their effusions or circulating blood. This may in fact represent a newly recognized form of KSHV-MCD, but our analysis continues. While certain of these participants were historically included in this study, given this new understanding, they will not be entered on this protocol and removed if liquid MCD is diagnosed.\n\n* Pregnancy\n* Any abnormality that would be scored as NCI CTC Grade 4 toxicity that is unrelated to HIV, its treatment, or to KICS that would preclude the use of all of the study treatments or the ability to monitor the natural history of KICS untreated.\n* Any condition or set of circumstances that in the opinion of the investigators would make participation in this study unsafe or otherwise inappropriate for a given individual.","ALL","18 Years","120 Years",{"count":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Background:\n\n\\- KSHV inflammatory cytokine syndrome (KICS) is a newly recognized disease caused by Kaposi sarcoma-associated herpesvirus (KSHV). This virus can cause cancer. People with KICS can have severe symptoms. They include fever, weight loss, and fluid in the legs or abdomen. People with KICS may also be at risk of getting other cancers associated with KSHV. These cancers include Kaposi sarcoma and lymphoma. Because KICS is a newly identified disease, more information is needed on how the disease works and what can be done to treat it.\n\nObjectives:\n\n\\- To collect genetic and medical information from people with KSHV inflammatory cytokine syndrome.\n\nEligibility:\n\n\\- Individuals at least 18 years of age who have Kaposi sarcoma herpes virus and symptoms that resemble those caused by KICS.\n\nDesign:\n\n* Participants will have regular study visits. The schedule will be determined by the study researchers.\n* Participants will provide a complete medical history and have a full physical exam. Blood and urine samples will be collected as well.\n* People with KICS that requires treatment may get new experimental treatments. These treatments may include antiviral drugs and chemotherapy drugs, depending on the nature of the disease.\n* Participants will have imaging studies, such as chest x-rays and computed tomography scans, to study the tumors.\n* Bone marrow and lymph node biopsies may be done to collect tissue samples for study.\n* Participants who have Kaposi sarcoma will have photographs taken of their lesions.",[26,27,28],"KSHV Inflammatory Cytokine Syndrome (KICS)","KSHV","HHV-8",[27,30,31,32,28],"KICS","HIV","Cytokines","RECRUITING","2026-09-19",{"date":36,"type":37},"2026-09-22","ACTUAL",{"date":39,"type":37},"2011-09-08",{"date":41,"type":20},"2028-12-31",{"name":43,"class":44},"National Cancer Institute (NCI)","NIH",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":45},"100520134","phase-2-phase-ii-study-of-pacritinib-in-kaposi-sarcoma-herpesvirus-kshv-associated-multicentric-castleman-disease-and-kshv-associated-inflammatory-cytokine-syndrome-kics-100520134","NCT06052618","Phase II Study of Pacritinib in Kaposi Sarcoma Herpesvirus (KSHV)-Associated Multicentric Castleman Disease and KSHV-Associated Inflammatory Cytokine Syndrome (KICS)","* INCLUSION CRITERIA:\n* Participants must meet KSHV-associated Inflammatory Cytokine Syndrome (KICS) criteria or have histologically or cytologically confirmed Kaposi sarcoma herpesvirus -multicentric Castleman disease (KSHV-MCD) confirmed by the CCR, Laboratory of Pathology (LP), NCI\n* Age \\>= 18 years\n* At least one clinical symptom attributed to KSHV-MCD or KICS, as follows:\n\n  * Intermittent or persistent fever for at least 1 week (\\>38 degrees C)\n  * Fatigue (CTCAE - Grade \\>=2)\n  * Gastrointestinal symptoms (e.g., nausea and anorexia - CTCAE Grade \\>=1)\n  * Respiratory symptoms (e.g., cough and airway hyperreactivity - CTCAE Grade \\>=1)\n* At least one laboratory abnormality attributed to KSHV-MCD or KICS, as follows:\n\n  * Anemia (hemoglobin \\[Hgb\\] 7.0 - 12.5gm\u002FdL)\n  * Thrombocytopenia (50,000 - 150,000\u002Fmm3)\n  * Hypoalbuminemia (\\\u003C3.4 g\u002FdL)\n  * Elevated C-reactive protein \\[CRP\\] (\\>3mg\u002FL)\n* No life or organ-threatening manifestations of KSHV-MCD, KICS or Kaposi Sarcoma (KS)\n* Eastern Cooperative Oncology Group \\[ECOG\\] performance status \\\u003C= 3 (Karnofsky \\>=60%)\n* Participants must have laboratory parameters as defined below:\n\n  * Total bilirubin \\\u003C=3 X upper limit of normal (ULN) or \\\u003C6X ULN for diagnosis of Gilbert's\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C=2.5 X ULN\n  * PT\u002FPTT\u002FINR \\\u003C=1.5 X ULN\n  * Creatinine within normal institutional limits OR Creatinine clearance \\>=30mL\u002Fmin\u002F1.73 m\\^2 as estimated by either Cockcroft-Gault or 24-hour urine collection for participants with creatinine levels above ULN\n* Participants with HIV should be receiving and willing to continue or willing to initiate an effective antiretroviral therapy (ART) regimen that excludes strong\u002F moderate CYP3A4 inducer or inhibitors.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, participants must be on suppressive therapy.\n* Participants with a history hepatitis C virus (HCV) infection must have completed treatment with evidence of sustained virologic response for a period of at least 3 months.\n* Participants with KSHV-MCD (Cohort 2) or KICS (Cohort 3) who have received prior therapy, such as rituximab or other monoclonal antibodies, must have a wash out period of at least 3 weeks.\n* Participants receiving medications or substances that are substitutes of strong CYP3A4 inhibitors must have a washout period of at least 5 half-lives of the drug prior to enrollment on study.\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (e.g., intrauterine device \\[IUD\\], hormonal \\[excluding hormonal contraceptives sensitive to CYP3A4 metabolism (i.e. progestin)\\], surgical sterilization, abstinence) prior to study entry, for the duration of study participation, and for up to 30 days after discontinuation of the study drug.\n* Individuals of child-bearing potential (IOCBP) and individuals able to father a child with a partner able to become pregnant must agree to use a highly effective method of contraception (e.g., intrauterine device \\[IUD\\], hormonal \\[excluding hormonal contraceptives sensitive to CYP3A4 metabolism (i.e. progestin, ethinylestradiol)\\], surgical sterilization, abstinence) prior to study entry, for the duration of study\n\nparticipation, and for up to 30 days after discontinuation of the study drug. A participant may request that partner uses the highly effective form of contraception to fulfill this requirement.\n\n-Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Grade \\>2 symptomatic visceral KS (except for edema or non-ulcerating disease restricted to the oral cavity).\n* History of allergic reactions attributed to compounds of similar chemical or biologic\n\ncomposition to pacritinib.\n\n* Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4. Lists including medications and substances known or with the potential to interact with the specified CYP3A4 isoenzymes.\n* Participants with evidence of ongoing hemorrhage, active signs\u002Fsymptoms of bleeding, or history of severe bleeding complications in the one year prior to enrollment.\n* Any history of CTCAE Grade \\>= 3 cardiac events within the last 3 months.\n* QTc(Fredericia) prolongation \\>480 ms or other factors that increase the risk for QTc prolongation (i.e., heart failure, or a history of long QT interval syndrome).\n* Use of concomitant medications with significant potential for QTc prolongation\n* History of thrombosis, troponin-positive (Tpos) or myocardial infarction within the last 6 months\n* Participants with moderate (Child-Pugh Score B) or severe hepatic impairment (Child-Pugh Score C)\n* Diagnosis of primary effusion lymphoma \\[PEL\\] or another lymphoma.\n* Participants with a prior or concurrent malignancy whose natural history or treatment that has potential to interfere with the safety or efficacy assessment of the regimen.\n* Pregnant individuals as evaluated by a positive serum or urine beta-hCG at screening.\n* There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing person with pacritinib. Breastfeeding should be discontinued if the nursing person is treated with pacritinib.\n* Uncontrolled bacterial, mycobacterial, or fungal infection at screening.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements, including results of hematology and chemistry testing, infection disease (etc.)",{"count":53,"type":20},75,[23],"Background:\n\nKaposi sarcoma herpesvirus (KSHV)-associated inflammatory cytokine syndrome (KICS) and KSHV-multicentric Castleman disease (MCD) occur in people living with HIV. These diseases cause severe inflammation that can be fatal if not treated.\n\nObjective:\n\nTo test a drug (pacritinib) in people with KSHV-associated KICS or MCD.\n\nEligibility:\n\nPeople aged 18 years and older with KSHV-associated KICS or MCD. They must have at least one symptom.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests and tests of their heart function. They will have imaging scans. Their ability to perform everyday tasks will be reviewed. In some participants who have Kaposi sarcoma (KS) with KICS or MCD, these individuals may need a bronchoscopy and\u002For endoscopy of the upper or lower intestine: A flexible tube with a camera and a light source will be inserted through the mouth or anus to see these structures and assess any KS.\n\nPacritinib is a capsule taken by mouth. Participants will take the drug twice a day, every day, for up to 24 weeks. They will write down each dose in a diary.\n\nParticipants will visit the clinic 3 times in the first 4 weeks. Their visits will taper to once every 4 weeks. Imaging scans, blood tests, and other tests will be repeated during these visits. Participants will give samples of saliva. They may opt to allow tissues samples to be taken from their skin and lymph nodes.\n\nParticipants will have follow-up visits 7 days and 30 days after their last dose of pacritinib. After that, they will visit the clinic every 3 months for up to 1 year. The physical exam and blood, heart, and imaging tests will be repeated at these visits.",[26,57],"Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease",[59,60,61,62,31],"JAK2","Interleukin-1","interleukin 6 receptor","Lymphoproliferative Disorder","2026-08-21",{"date":65,"type":37},"2026-08-24",{"date":67,"type":37},"2025-03-17",{"date":69,"type":20},"2034-01-01",{"name":43,"class":44}]