History of the KSHV Inflammatory Cytokine Syndrome (KICS)
|First Received Date ICMJE||August 17, 2011|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||August 3, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Assessment of the natural history of KICS, including the spectrum of clinical, laboratory and radiographic abnormalities seen in affected patients. [ Time Frame: 5 years ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01419561 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||History of the KSHV Inflammatory Cytokine Syndrome (KICS)|
|Official Title ICMJE||Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS) Incorporating Pilot Evaluation of KSHV Targeted Therapies|
- 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.
- To collect genetic and medical information from people with KSHV inflammatory cytokine syndrome.
- Individuals at least 18 years of age who have Kaposi sarcoma herpes virus and symptoms that resemble those caused by KICS.
KSHV inflammatory cytokine syndrome (KICS) is a newly recognized syndrome caused by Kaposi sarcoma-associated herpesvirus (KSHV). It is characterized by severe inflammatory symptoms including fevers, wasting, cytopenias, hypoalbuminemia, and hyponatremia, associated in some cases with lymphadenopathy or effusions, without pathological evidence of MCD. Patients with KICS exhibit elevated KSHV viral loads and cytokine dysregulation, with elevations of IL-6, IL-10, and a KSHV-encoded IL-6 homolog, viral IL-6.
The primary study objective is to enable intensive study and description of the natural history of KICS. Secondary objectives include assessment in affected persons of KSHV viral loads and cytokine levels, evaluation of tissue pathophysiology, exploration of FDG-PET abnormalities, and pilot assessment of response to two therapies: high dose zidovudine/valganciclovir or rituximab/liposomal doxorubicin.
Adults of any HIV status with:
Patients with these characteristics will be further evaluated to identify those whose clinical and laboratory features are consistent with the working KICS working case definition to be followed in the natural history phase of the study.
This is a single center natural history cohort with an observation arm and two nested open label pilot treatment arms, and an accrual ceiling of 40 patients to the overall natural history arm. Natural history patients will undergo clinical, laboratory and correlative assessment every 3 months until sustained resolution. Patients with clinical and laboratory manifestations of KICS, elevated inflammatory markers and KSHV viral load will be eligible for therapy with high dose zidovudine/valganciclovir or, if they have intercurrent KS requiring cytotoxic therapy, rituximab/liposomal doxorubicin. Each treatment arm uses a two stage design, with interim analysis at 8 patients in each arm and potential accrual of 14 per arm.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||80|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 99 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01419561|
|Other Study ID Numbers ICMJE||110220
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Cancer Institute (NCI)|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 7, 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP