Cytomegalovirus Infections Clinical Trial
Official title:
The Efficiency and Safety of Low Dose IL-2 and Ganciclovir in Treatment of Cytomegalovirus Infection: an Open Label, Prospective and Control Trial
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.
In rheumatic diseases, CMV infection are more frequent in patients after corticosteroid pulse
treatment and long-term treatment of corticosteroid and immunosuppressor.
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, The CMV-DNA levels will be monitored until it
turned out to be negative. In this period, we will simultaneously monitor the immune response
in regard to CMV infection, including innate immune response, such as IFN-γ, TNF-α, natural
killer cells, and adaptive immune response, such as CMV specific CD8+ T cells, T helper cells
and so on.
We will follow these patients for at least 3 months after drug withdrawal. If patient
belonging to any of these two groups develops a viral infection, then the patient will
receive treatment with ganciclovir.
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