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

NCT04664127 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2020-12-11

No results posted yet for this study

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

Interventions

DRUG

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

DRUG

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.

Sponsors & Collaborators

  • Nearmedic Plus LLC

    lead INDUSTRY

Principal Investigators

  • Georgy Vikulov, Ph.D · Scientific Information Center for Prevention and Treatment of Viral Infections

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-30
Primary Completion
2018-10-29
Completion
2018-10-29

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04664127 on ClinicalTrials.gov