Interleukin-2 (IL-2): Low-dose IL-2 at 1MIU will be administered subcutaneously every other day from baseline to CMV negativity.
Ganciclovir (GCV): Ganciclovir injection will be administrated intravenously at a dose of 5mg/kg per day.
Study summary
This clinical trial will assess the efficacy and safety of low-dose interleukin-2 (IL-2) treatment in systemic lupus erythematosus (SLE) complicated with cytomegalovirus (CMV) viremia.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Meet the American College of Rheumatology criteria for the diagnosis of SLE.
* The test for plasma CMV DNA viral load is positive.
* Age: 18 to 65 years, weight 45-80kg, male or female, gender ratio is not limited.
* Apply corticosteroid less than 1.0mg/kg/d.
* Written informed consent form.
Exclusion Criteria:
* Inability to comply with IL-2 treatment regimen;
* Other active infections. (hepatitis B or C virus, Epstein-Barr virus, human immunodeficiency virus, Mycobacterium tuberculosis or pneumocystis carinii pneumonia)
* Any anti-CMV vaccine within 6 months;
* History of intravenous immunoglobulin (IVIG) or leflunomide within 6 months prior to randomization, and those who have undergone plasmapheresis;
* Active severe neuropsychiatric manifestations of SLE;
* Severe chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases\> 3N));
* Severe complications. (respiratory failure, heart failure or toxic shock)
* Complicated with other autoimmune diseases;
* Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
* Pregnancy or lactation in females.
* Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;
* Participate in other clinical trial within 3 months.
Primary outcome measure(s)
Changes of NK cell levels — Baseline and week 12 Changes of absolute NK cell count and NK%.
Trial sites (1)
Facility
City
Region
Status
Peking University People's Hospital
Beijing
Bejing
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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