Efficacy and Safety of Low-dose IL-2 in SLE Patients With CMV Viremia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interleukin-2 (IL-2), Ganciclovir (GCV).
- Who it may be relevant to
- Registry conditions: SLE (Systemic Lupus), CMV. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs, and infection is the leading cause of death in SLE. SLE patients are prone to opportunistic infections such as CMV viremia due to treatments with glucocorticoids and immunosuppressives. CMV viremia is a life-threatening complication in the immunocompromised population, which could establish a state of long-term latency following infection. Once CMV is reactivated in hosts, the immune system would be attacked, resulting in exacerbating SLE disease condition.
While traditional available therapies for SLE patients with CMV viremia, to a certain extent, have improved the outcome of these patients, there remains many patients who are antiviral drug-resistant or nonresponsive in clinical practice. Thus, there is an unmet need for safe and more effective treatments. In preliminary clinical trials, we have demonstrated low-dose IL-2 is safe and efficient in autoimmune diseases, including rheumatoid arthritis and SLE. In addition, in spite of sacrificing anti-infection immune function as most immunosuppressive drugs, low-dose IL-2 therapy lowered incidence of infections by upregulating the level of natural killer (NK) cells in SLE patients. In addition, low-dose IL-2 therapy is much less economically burdensome than intravenous immunoglobulin. We hypothesized that low-dose IL-2 could be a novel therapy in SLE patients with CMV viremia.
This is a multicenter, prospective and controlled study to evaluate the efficacy/safety of low-dose IL-2 plus ganciclovir in SLE with active CMV infection.
Methods: SLE patients with CMV viremia will be enrolled and randomly assigned (1:1 ratio) to two groups, low-dose IL-2 group or control group in this study. IL-2 group are going to be treated with low-dose IL-2 plus ganciclovir. Low-dose IL-2 at 1MIU will be administered subcutaneously every other day from baseline to CMV negativity. Ganciclovir injection will be administrated intravenously at a dose of 5mg/kg per day. Control group are going to be treated with ganciclovir. Weekly follow-ups visits will be conducted until participants became CMV negative, the criteria for withdrawing from the trial. The endpoints were changes in NK cells, duration of CMV viremia, clinical, immunologic responses and safety.
Interventions
- Drug Interleukin-2 (IL-2)
Low-dose IL-2 at 1MIU will be administered subcutaneously every other day from baseline to CMV negativity. - Drug Ganciclovir (GCV)
Ganciclovir injection will be administrated intravenously at a dose of 5mg/kg per day.
Primary outcome measures
- Changes of NK cell levels [Time frame: Baseline and week 12]
Secondary outcome measures (5)
- Duration of CMV viremia [Time frame: From enrollment to the end of treatment]
- Change of CMV titers [Time frame: From enrollment to the end of treatment]
- Immune responses [Time frame: Baseline and Week 12]
- • Complements levels [Time frame: Baseline and week 12]
- Adverse events (AEs) [Time frame: Baseline and week 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT06971913 · SLE-CMV-IL2