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New treatment option for KSHV Inflammatory Cytokine Syndrome (KICS)
Official title Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)
ClinicalTrials.gov ID: NCT01419561
What this study is testing
What is Zidovudine?
Zidovudine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for kshv inflammatory cytokine syndrome (kics).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: \- KSHV inflammatory cytokine syndrome (KICS) is a newly recognized disease caused by Kaposi sarcoma-associated herpesvirus (KSHV). This virus can cause cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Clinical symptoms (each at least grade 1 by CTCAE definitions)
- Fever (\>38 degrees C), chills or rigors
You likely can't join if
- \- Biopsy proven KSHV-associated MCD, confirmed in the LP, CCR, NCI. Note: In collaboration with LP, we have recently found that some participants...
- 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...
- Any condition or set of circumstances that in the opinion of the investigators would make participation in this study unsafe or otherwise...
See the full eligibility 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...
- 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...
- \- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.