New study targets rare Virus-Driven inflammatory syndrome
NCT ID NCT01419561
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 11 times
Summary
This study looks at a newly recognized disease called KSHV Inflammatory Cytokine Syndrome (KICS), caused by a virus that can also lead to certain cancers. Researchers aim to learn more about the disease and test experimental treatments, including antiviral and chemotherapy drugs, in people with KICS. The study involves regular check-ups, blood tests, and imaging to track the disease and response to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Zidovudine, liposomal doxorubicin, and valganciclovir (antiviral and chemotherapy drugs)
- What this could lead to
- If successful, this study could lead to better understanding and treatment options for KICS, a severe inflammatory condition caused by a virus.
- What could go wrong
- This is an early-phase study with a small number of participants, so results may not apply to everyone. The treatments can have side effects, and it's unclear if they will effectively control the disease long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2011
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * 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 CRITERIA: \- Biopsy proven KSHV-associated MCD, confirmed in the LP, CCR, NCI. Note: 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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