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

Conditions

• Herpes
• Herpes Genitalis
• Herpes Oral
• Herpes Simplex
• Herpes Simplex 2

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

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
• 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.

Study Details

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.

Key Dates

Start date

Oct 30, 2017

Status verified

Jan 2019

Primary completion

Oct 29, 2018

Completion

Oct 29, 2018

Study Design

Enrollment

45 participants (actual)

Arms

• Arm: Combination therapy (Kagocel + Valacyclovir: n=25)
  Therapy according to routine practice (including Kagocel). Groups will be splitted during the final data analysis.
• Arm: Monotherapy by Valacyclovir (n=20)
  Therapy according to routine practice. Groups will be splitted during the final data analysis.

Primary Outcome Measure

Change of the patients proportion with different localizations of herpes simplex exacerbations. [ Time Frame: 2 points: before and 6 months after the start of therapy ]