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Natural History Study of KSHV Inflammatory Cytokine Syndrome (KICS)

This study is looking into KSHV Inflammatory Cytokine Syndrome (KICS), a newly identified illness caused by the Kaposi sarcoma-associated herpesvirus (KSHV). People with KICS can experience severe symptoms like fever, weight loss, and fluid buildup. This study aims to understand how KICS progresses over time and what treatments might help. Researchers will collect genetic and medical information from participants. Interventions include Zidovudine, Liposomal Doxorubicin, Valganciclovir, Rituximab, and standard therapies. You might be able to join if you are an adult with at least two symptoms, lab results, or X-ray findings possibly related to KICS, have evidence of KSHV infection, and a C-reactive protein level above 3mg/L. The main goal is to observe the natural course of KICS for one year.

Study design
This is an interventional study with a planned enrollment of 140 participants. The study involves several different drug interventions, including Zidovudine, Liposomal Doxorubicin, Valganciclovir, Rituximab, and standard therapies.
What's involved
Participants will receive Zidovudine, Liposomal Doxorubicin, Valganciclovir, and/or Rituximab according to specific schedules for cycles of 7 to 14 days.
Compensation
Not stated in the trial record.
Follow-up
The natural history of KICS will be measured at one year.

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NCT01419561

Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)

Recruiting
PHASE2Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~140 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:ZidovudineLiposomal DoxorubicinValganiclovirRituximabStandard TherapiesCohort 1

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Natural history of KICS
Measured over one year

Conditions

KSHV Inflammatory Cytokine Syndrome (KICS)
KSHV
HHV-8

Explore related trials

KSHV Inflammatory Cytokine SyndromeKSHV

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Robert Yarchoan, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Ijeoma M Agwu
[email protected]
(240) 858-7435
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age greater than or equal to18 Years.
Any HIV status.
At least two manifestations drawn from at least two of the categories (clinical symptoms, laboratory abnormalities and/or radiographic abnormalities), which are at least possibly attributable to KICS and are not readily explicable from known medical conditions in the participant:
Clinical symptoms (each at least grade 1 by CTCAE definitions)
Fever (\>38 degrees C), chills or rigors
Fatigue or lethargy
Cachexia or edema
Cough, dyspnea, airway hyperreactivity, or nasal inflammation
Nausea, anorexia, abdominal pain or altered bowel habit
Athralgia or myalgia
Altered mental state
Neuropathy with or without pain
Laboratory abnormalities
Anemia (hemoglobin\<12.0g/dL)
Thrombocytopenia (platelets\<100,000 cells/microL)
Leukopenia (white cell count\<4,000 cells/microL)
Hypoalbuminemia (albumin\<3.5g/dL)
Hyponatremia (sodium\<135mmol/L)
Coagulopathy (PT or PTT \>1.5 times upper limit of normal)
Radiographic abnormalities
Pathologic lymphadenopathy (at least five discrete nodes each \>1cm in their longest dimension)
Splenomegaly (\>12 cm in the longest dimension)
Hepatomegaly (\>17cm in the longest dimension)
Body cavity effusions not caused by primary effusion lymphoma nor chylous effusions directly related to lymphatic infiltration by KS
C-reactive protein (CRP) \>3mg/L.
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:
Molecular evidence of KSHV in whole blood, or KSHV VL levels within circulating PBMCs as determined by the Whitby laboratory
Immunohistochemical evidence of KSHV in tissues (for example by staining for LANA or vIL-6) confirmed in the Laboratory of Pathology (LP), CCR, NCI.
Presence of KS or PEL (KSHV-associated malignancies), confirmed in the LP, CCR, NCI.
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.

Exclusion

Pregnancy
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.
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.

What this trial measures

  • Natural history of KICSone year

    Description of the natural history of KICS, including the spectrum of clinical, laboratory and radiographic abnormalities seen in affected patients