Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel

NCT04664127 | Completed

• 1 other identifier: version 1.0 from 20.10.2017
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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 when combined therapy by acyclic nucleoside Valacyclovir and antiviral agent Kagocel versus monotherapy by Valacyclovir. This study also evaluated the structure of herpesvirus infections and the rate of mixed variants of the course, the rate of exacerbations of herpes simplex, the time of disappearance of human herpesvirus isolation and the features of the immune phenotype of patients taking different types of therapy.

Conditions

Herpes; Herpes Simplex; Herpes Oral; Herpes Simplex 2; Herpes Genitalis

Keywords

herpes simplex; HSV1; HSV2; Herpes Genitalis; Herpes Oral; herpes simplex viruses; Valaciclovir

Outcome Measures

Primary Outcomes (4)

• Change of the patients proportion with different localizations of herpes simplex exacerbations.

  2 points: before and 6 months after the start of therapy

• Change of the rate of exacerbations of orolabial, genital and other localization herpes simplex

  2 points: before and 6 months after the start of antiviral therapy

• Change of the number of patients with varying degrees of severity illness

  2 points: before and 6 months after the start of therapy

• Change in the number of local complaints (pain, itching, burning, rash) against the background of a recurrence of herpes simplex

  up to 6 months

Secondary Outcomes (11)

• Number of participants with treatment-related adverse events (AE) with regards to type and severity of AE (mild, moderate, severe; according to physician's opinion)

  up to 6 (12) mounts

• Change of the duration of each herpes simplex relapse and the rate of epithelialization

  2 points: before and 6 days after the start of therapy

• Change of the occurrence rate of morphological elements of the rash and General symptoms

  4 points: 1-before the start of therapy, 2-6 days after the start of therapy, 3-30 days, 4-4 months

• Change of the rate of herpes simplex rash (relapses)

  4 points: 1 - before the start of therapy, 2 - 6 days after the start of therapy, 3 - 30 days, 4 - 4 months

• Change of the intensity of herpes simplex exacerbations in points

  4 points: 1-before the start of therapy, 2-6 days after the start of therapy, 3-30 days, 4-4 months

Study Arms (2)

Combination therapy (Kagocel + Valacyclovir: n=25)

Therapy according to routine practice (including Kagocel). Groups will be splitted during the final data analysis.

Drug: Kagocel+Valacyclovir

Monotherapy by Valacyclovir (n=20)

Therapy according to routine practice. Groups will be splitted during the final data analysis.

Drug: Valacyclovir

Interventions

Kagocel+Valacyclovir DRUG

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

Combination therapy (Kagocel + Valacyclovir: n=25)

Valacyclovir DRUG

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.

Monotherapy by Valacyclovir (n=20)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult men and women with signs of severe herpes simplex.

You may qualify if:

• Patients ≥ 18 years old
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nearmedic Plus LLC: lead

Study Sites (1)

Scientific Information Center for Prevention and Treatment of Viral Infections

Moscow, 117198, Russia

Location

Related Links

• 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

MeSH Terms

Conditions

Herpes Simplex; Herpes Genitalis

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Georgy Vikulov, Ph.D

  Scientific Information Center for Prevention and Treatment of Viral Infections

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 11, 2020
• Study Start: October 30, 2017
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: December 11, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)