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New drug trial targets deadly inflammation in HIV patients

NCT ID NCT06052618

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This study tests a drug called pacritinib in people with HIV who have two rare conditions caused by the Kaposi sarcoma herpesvirus (KSHV): KSHV-associated multicentric Castleman disease (MCD) and KSHV inflammatory cytokine syndrome (KICS). These conditions cause severe, life-threatening inflammation. The drug is taken as a capsule twice daily for up to 24 weeks. The goal is to see if pacritinib can reduce symptoms and control the disease. About 75 adults with at least one symptom (like fever or fatigue) will participate.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jan 2034

An estimate. End dates often move.

Lead sponsor

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

18 to 120 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: * 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 * Age \>= 18 years * At least one clinical symptom attributed to KSHV-MCD or KICS, as follows: * Intermittent or persistent fever for at least 1 week (\>38 degrees C) * Fatigue (CTCAE - Grade \>=2) * Gastrointestinal symptoms (e.g., nausea and anorexia - CTCAE Grade \>=1) * Respiratory symptoms (e.g., cough and airway hyperreactivity - CTCAE Grade \>=1) * At least one laboratory abnormality attributed to KSHV-MCD or KICS, as follows: * Anemia (hemoglobin \[Hgb\] 7.0 - 12.5gm/dL) * Thrombocytopenia (50,000 - 150,000/mm3) * Hypoalbuminemia (\<3.4 g/dL) * Elevated C-reactive protein \[CRP\] (\>3mg/L) * No life or organ-threatening manifestations of KSHV-MCD, KICS or Kaposi Sarcoma (KS) * Eastern Cooperative Oncology Group \[ECOG\] performance status \<= 3 (Karnofsky \>=60%) * Participants must have laboratory parameters as defined below: * Total bilirubin \<=3 X upper limit of normal (ULN) or \<6X ULN for diagnosis of Gilbert's * AST(SGOT)/ALT(SGPT) \<=2.5 X ULN * PT/PTT/INR \<=1.5 X ULN * Creatinine within normal institutional limits OR Creatinine clearance \>=30mL/min/1.73 m\^2 as estimated by either Cockcroft-Gault or 24-hour urine collection for participants with creatinine levels above ULN * Participants with HIV should be receiving and willing to continue or willing to initiate an effective antiretroviral therapy (ART) regimen that excludes strong/ moderate CYP3A4 inducer or inhibitors. * For participants with evidence of chronic hepatitis B virus (HBV) infection, participants must be on suppressive therapy. * 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. * 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. * 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. * 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. * 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 participation, 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. -Ability of participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Grade \>2 symptomatic visceral KS (except for edema or non-ulcerating disease restricted to the oral cavity). * History of allergic reactions attributed to compounds of similar chemical or biologic composition to pacritinib. * 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. * Participants with evidence of ongoing hemorrhage, active signs/symptoms of bleeding, or history of severe bleeding complications in the one year prior to enrollment. * Any history of CTCAE Grade \>= 3 cardiac events within the last 3 months. * 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). * Use of concomitant medications with significant potential for QTc prolongation * History of thrombosis, troponin-positive (Tpos) or myocardial infarction within the last 6 months * Participants with moderate (Child-Pugh Score B) or severe hepatic impairment (Child-Pugh Score C) * Diagnosis of primary effusion lymphoma \[PEL\] or another lymphoma. * 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. * Pregnant individuals as evaluated by a positive serum or urine beta-hCG at screening. * 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. * Uncontrolled bacterial, mycobacterial, or fungal infection at screening. * Uncontrolled intercurrent illness that would limit compliance with study requirements, including results of hematology and chemistry testing, infection disease (etc.)

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.