Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel
NCT ID: NCT04664127
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
45 participants
OBSERVATIONAL
2017-10-30
2018-10-29
Brief Summary
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Detailed Description
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This research did not include any procedures or medical interventions except those recommended in the local clinical guidelines and international standards of care. All procedures and evaluations were performed in accordance with routine clinical practice adopted in the Russian Federation and the instructions for the medical use of drugs that patients received.
The following data was collected and analyzed after the end of treatment:
* demography
* disease severity (mild, moderate, severe, continuous relapses)
* data of anamnesis (hereditary and family anamnesis, duration of herpes simplex disease, previous illnesses, duration of treatment, previous treatment of herpes simplex and its efficacy, allergic anamnesis, epidemiological anamnesis, rate and duration of herpes relapses over the past year (with indication of the location of herpes simplex rashes), main diagnosis and complications, ICD-10 code, date and time of the last exacerbation, causes of exacerbation)
* verification of inclusion criteria
* verification of non-inclusion criteria
* prescribed therapy (trade name and prescription scheme, rate, method of administration)
* laboratory tests (4 timelines: 1 - first 6-48 hours; 2 - 6 days after starting of therapy; 3 - 30 days; 4 - 4 months): clinical and biochemical blood tests; serological diagnostics with determination of herpes virus infections's markers: IgM, IgG-HSV1, HSV2; hospital screening of venous blood: anti - HIV-1,2; anti-HCV-total, HBsAg, CSR; microbiological seeding from the tonsils, posterior pharyngeal wall with determination of drug sensitivity; PCR of blood, saliva and/or rash elements; immune status by laser flow cytometry: CD3+, CD4+, CD8+, CD4+/CD8+, CD16+, CD19+; serum immunoglobulins: IgA, IgM, IgG, IgE total.
* medical anamnesis (4 timelines: 1 - first 6-48 hours; 2 - 6 days after starting of therapy; 3 - 30 days; 4 - 4 months) or clinical efficacy: the presence and rate of exacerbations of the disease orolabial, genital and other sites; local complaints; the rate of occurrence of and general symptoms; the rate of epithelialization of the rash's morphological elements; duration of recurrence of the herpes simplex virus and speed of onset of epithelialization; the rate of relapses and exacerbations of herpes simplex on the background of suppressive therapy
* taking other drugs during the study (trade name, prescription scheme)
* compliance with the drugs regimen
* timelines: data of signing the informed consent, start date of the study, date of each patient visit, end date of the study, start date and end date of the taking medicines, duration of patient follow-up)
* quality of life assessment at the end of the study (excellent / good / satisfactory / has not changed)
* adverse events (yes/no, data description)
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Combination therapy (Kagocel + Valacyclovir: n=25)
Therapy according to routine practice (including Kagocel). Groups will be splitted during the final data analysis.
Kagocel+Valacyclovir
Group 1-patients with simple severe herpes (HSV-infection orolabial and / or genital localization) treatment \[Valacyclovir + Kagocel ° \] (n= 25).
Treatment: Valacyclovir, 1000 mg orally (2 tablets of 500 mg): 1 time per day for at least 4 months continuously (the rate of suppressive therapy). \* Kagocel®, 24 mg orally (2 tablets of 12 mg): 3 times per day, 5 days continuously.
\* - During the study the minimum duration of Valacyclovir suppressive therapy in instruction for medical use that drag was changed from 4 (what was using in our reserch) to 6 months, and the optimal duration of continuous antiviral therapy with PG was changed from 6 to 12 months
Monotherapy by Valacyclovir (n=20)
Therapy according to routine practice. Groups will be splitted during the final data analysis.
Valacyclovir
Group 2 -patients with simple severe herpes (HSV-infection orolabial and/or genital localization) receiving treatment \[Valacyclovir\] (n= 20).
Scheme of treatment: Valacyclovir, 1000 mg orally (2 tablets of 500 mg): 1 time per day for at least 4 months continuously (a course of suppressive therapy)\*.
\* - During the study the minimum duration of Valacyclovir suppressive therapy in instruction for medical use that drag was changed from 4 (what was using in our reserch) to 6 months, and the optimal duration of continuous antiviral therapy with PG was changed from 6 to 12 months.
Interventions
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Kagocel+Valacyclovir
Group 1-patients with simple severe herpes (HSV-infection orolabial and / or genital localization) treatment \[Valacyclovir + Kagocel ° \] (n= 25).
Treatment: Valacyclovir, 1000 mg orally (2 tablets of 500 mg): 1 time per day for at least 4 months continuously (the rate of suppressive therapy). \* Kagocel®, 24 mg orally (2 tablets of 12 mg): 3 times per day, 5 days continuously.
\* - During the study the minimum duration of Valacyclovir suppressive therapy in instruction for medical use that drag was changed from 4 (what was using in our reserch) to 6 months, and the optimal duration of continuous antiviral therapy with PG was changed from 6 to 12 months
Valacyclovir
Group 2 -patients with simple severe herpes (HSV-infection orolabial and/or genital localization) receiving treatment \[Valacyclovir\] (n= 20).
Scheme of treatment: Valacyclovir, 1000 mg orally (2 tablets of 500 mg): 1 time per day for at least 4 months continuously (a course of suppressive therapy)\*.
\* - During the study the minimum duration of Valacyclovir suppressive therapy in instruction for medical use that drag was changed from 4 (what was using in our reserch) to 6 months, and the optimal duration of continuous antiviral therapy with PG was changed from 6 to 12 months.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Nearmedic Plus LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Georgy Vikulov, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Scientific Information Center for Prevention and Treatment of Viral Infections
Locations
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Scientific Information Center for Prevention and Treatment of Viral Infections
Moscow, , Russia
Countries
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Related Links
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Vikulov G., Voznesenskiy S. Сombination antiviral therapy of herpes simplex // Vrach. - 2019; 30 (5): 27-34. https://doi.org/10.29296/25877305-2019- 05-05
Vikulov G.Kh., Voznesenskiy S.L. Combination antiviral therapy in patients with severe herpes simplex virus infections: clinical and immunological characteristics and assessment of patients' quality of life. Infectious diseases. 2019; 17(4): 79-91
Other Identifiers
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version 1.0 from 20.10.2017
Identifier Type: -
Identifier Source: org_study_id