Treatment of Low Dose IL-2 and Ganciclovir in Cytomegalovirus Infection
The Efficiency and Safety of Low Dose IL-2 and Ganciclovir in Treatment of Cytomegalovirus Infection: an Open Label, Prospective and Control Trial
1 other identifier
interventional
10
0 countries
N/A
Brief Summary
Cytomegalovirus (CMV) infections is a severe infection in patients of rheumatic disease treated with corticosteroid and immunosuppressive agents. Ganciclovir is the main therapy in CMV infection, accompanied with diverse side effects, including neutropenia, anemia, disorder of renal function and so on, which are also common symptoms of rheumatic diseases. Additionally, prolonged antiviral treatment may delay recovery of virus, specific immune responses, resulting in an increasing of late-onset CMV disease. IL-2 is a pleotropic cytokine which can promote the proliferation and function of CD8+ T cells and NK cells through the combination with IL-2 receptor. Recently, several studies have revealed that low dose IL-2 is an effective and safe therapy for autoimmune disease. In systemic lupus erythematous patients, additionally, patients treated with low-dose IL-2 had lower incidence of infection with increased percentages of natural killer (NK) cells. In this prospective clinical trial, we propose to assess the effective and safety of low-dose IL-2 combined with ganciclovir in the treatment of CMV infection. Meanwhile, we will assess the immune response of after IL-2 treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedJanuary 13, 2020
January 1, 2020
11 months
January 9, 2020
January 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline of NK cells cytotoxicity after treatment
NK cells cytotoxicity will be detected by flow cytometry
Days 7 after treatment
Secondary Outcomes (6)
The total dose for anti-viral drugs.
Day for drug withdrawal.
The change of cytokine after low-dose IL-2 treatment.
Day after anti-viral treatment and 3 months.
The change of NK cell subsets.
Day after anti-viral treatment and 3 months.
The change of level of CMV immunoglobulin M (IgM)
Day for drug withdrawal and 3 months.
The change of level of CMV immunoglobulin G (IgG)
Day for drug withdrawal and 3 months.
- +1 more secondary outcomes
Study Arms (2)
Treatment of low-dose IL-2 and ganciclovir
EXPERIMENTALIf patients are eligible, which CMV-DNA are more than 10\^3 copies, it will be randomly distributed in low-dose IL-2 and ganciclovir group and low-dose IL-2 is defined as 1 million IU per day subcutaneously.
Treatment of ganciclovir
PLACEBO COMPARATORIf patients are eligible, which CMV-DNA are more than 10\^3 copies, it will be randomly distributed in ganciclovir treatment group.
Interventions
If patients are eligible, which CMV-DNA are more than 10\^3 copies, it will be randomly distributed in low-dose IL-2 and ganciclovir group, or ganciclovir group. Low-dose IL-2 is defined as 1 million IU per day subcutaneously.
Eligibility Criteria
You may qualify if:
- Diagnosis of Rheumatic disease by the Criteria ;
- Patients have current CMV infection, CMV-DNA are positive.
- Apply corticosteroid less than 1.0mg/kg/d.
You may not qualify if:
- CMV-DNA is negative.
- Other infection, such as bacteremia, hepatitis B and C viruses, HIV, syphilis, bacteremia, Epstein-Barr virus and so on.
- Known allergies, hypersensitivity, or intolerance to IL-2 or its excipients.
- Severe comorbidities: including 1) Heart failure (≥ grade III NYHA); 2) Renal insufficiency (creatinine clearance ≤30 ml/min); 3) Hepatic insufficiency (serum ALT or AST \>3 times the ULN, or total bilirubin \>ULN for the central laboratory conducting the test); 4) Other disease including hematopathy, gastrointestinal disease, endocrinopathy, pulmonary, neuropathy.
- Malignancy.
- Had uncontrolled psychiatric or emotional disorder.
- Pregnant or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
He J, Zhang R, Shao M, Zhao X, Miao M, Chen J, Liu J, Zhang X, Zhang X, Jin Y, Wang Y, Zhang S, Zhu L, Jacob A, Jia R, You X, Li X, Li C, Zhou Y, Yang Y, Ye H, Liu Y, Su Y, Shen N, Alexander J, Guo J, Ambrus J, Lin X, Yu D, Sun X, Li Z. Efficacy and safety of low-dose IL-2 in the treatment of systemic lupus erythematosus: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2020 Jan;79(1):141-149. doi: 10.1136/annrheumdis-2019-215396. Epub 2019 Sep 19.
PMID: 31537547BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhanguo Li, PhD MD
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2020
First Posted
January 13, 2020
Study Start
February 1, 2020
Primary Completion
December 31, 2020
Study Completion
March 30, 2021
Last Updated
January 13, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share