Status:
COMPLETED
Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel
Lead Sponsor:
Nearmedic Plus LLC
Conditions:
Herpes
Herpes Simplex
Eligibility:
All Genders
18-100 years
Brief Summary
This study examined the efficacy, safety and benefits of modern treatment and changes in the dynamics of the life of adult patients quality with severe herpes simplex in the current medical practice w...
Detailed Description
This study was a comparative post-registration prospective non-interventional (observational) scientific study. This research did not include any procedures or medical interventions except those reco...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years old
- The absence of systemic etiotropic antiviral and immunosuppressive therapy for at least a year at the time of inclusion in this study
- Severe herpes simplex (HSV infection with orolabial and / or genital localization) with a recurrence rate of 6 or more for last 12 months.
- The first 6-48 hours after the exacerbation of herpes simplex.
- The following diseases and conditions are missing, usually requiring combination therapy by more than 2 drugs: ophthalmic herpes, visceral herpes, herpetic encephalitis, Kaposi's herpetiform eczema, primary immunodeficiency (PID criteria are given below\*), tuberculosis, ARVI and influenza symptoms (not related to herpesviruses), diabetes mellitus, hepatitis B and/or C, autoimmune diseases, HIV infection, other diseases requiring specific treatment (syphilis, gonorrhea), septic conditions, cancer (except of benign skin growths), mental illness, alcohol and/or drug addiction, artificial radiation and/or radiation therapy.
- Standard Valacyclovir therapy prescribed by doctor, or combination therapy by Valacyclovir and Kagocel.
Exclusion
- Basic cytostatic therapy, taking systemic glucocorticoids for life indications. Treatment by immunoglobulins and any vaccines for 30 days prior to inclusion in the study.
- Early period (up to 1 month) after any vaccination.
- Pregnancy, including pregnancy planning for 3 months and lactation.
- The presence of a genetic disease or verified primary immunodeficiency.
- Anamnesis of transplantation of organs and tissues.
- Plasmapheresis and blood donation for less than 6 months before the present study.
- Severe kidney and liver damage.
- Any other diseases or conditions that, by the opinion of the researcher, may interfere the patient from being included in the study.
Key Trial Info
Start Date :
October 30 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 29 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04664127
Start Date
October 30 2017
End Date
October 29 2018
Last Update
December 11 2020
Active Locations (1)
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1
Scientific Information Center for Prevention and Treatment of Viral Infections
Moscow, Russia, 117198