HerpesNCT04664127
Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel
An observational study of Herpes and Herpes Simplex, run by Nearmedic Plus LLC at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Herpes, Herpes Simplex, Herpes Oral
- What is being tested?
- Kagocel+Valacyclovir and Valacyclovir
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- 1 siteRussia
- Study dates
- 30 Oct 2017to 29 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult men and women with signs of severe herpes simplex.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Scientific Information Center for Prevention and Treatment of Viral Infections
Moscow, 117198
About this study
Official title: Clinical and Immunological Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection) by Acyclic Nucleoside Valacyclovir and Interferon Inducer Kagocel
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.
Read the 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 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
- Herpes, Herpes Simplex, Herpes Oral, Herpes Simplex 2, Herpes Genitalis
- Being tested
- Kagocel+Valacyclovir, Valacyclovir
- Keywords
- herpes simplex, HSV1, HSV2, Herpes Genitalis, Herpes Oral, herpes simplex viruses, Valaciclovir
- Medical subject headings
- Herpes Simplex, Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kagocel+ValacyclovirDrug
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
ValacyclovirDrug
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 group | Role | What they receive |
|---|---|---|
| Combination therapy (Kagocel + Valacyclovir: n=25) | Therapy according to routine practice (including Kagocel). Groups will be splitted during the final data analysis. Receives: Drug: Kagocel+Valacyclovir | |
| Monotherapy by Valacyclovir (n=20) | Therapy according to routine practice. Groups will be splitted during the final data analysis. Receives: Drug: Valacyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the patients proportion with different localizations of herpes simplex exacerbations.
Measured: 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
Measured: 2 points: before and 6 months after the start of antiviral therapy
Change of the number of patients with varying degrees of severity illness
Measured: 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
Measured: 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)
Measured: up to 6 (12) mounts
Change of the duration of each herpes simplex relapse and the rate of epithelialization
Measured: 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
Measured: 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)
Measured: 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
Herpes simplex exacerbation were local symptoms (according to the patient's assessment: pain, itching, burning, rash); localization of the rash (according to the doctor's assessment: orolabial, genital, other); morphology of the rash (ulcer and / or erosion, vesicle, crust, spot); intensity of the rash (single element, several elements, multiple rashes); enlarged lymph nodes; general symptoms (weakness, drowsiness, decreased physical activity, increased body temperature).
There was used subjective assessment: 1 point - min, 10 points - max intensity.
Measured: 4 points: 1-before the start of therapy, 2-6 days after the start of therapy, 3-30 days, 4-4 months
Change in the number of herpes viruses in saliva and blood by PCR
Identification of herpes viruses type 1 and 2 (HSV1, HSV2), cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpesvirus type 6 (HHV6, HHV7, HHV8) and assessment of the duration of their isolation.
Measured: 4 points: 1-before the start of therapy, 2-6 days after the start of therapy, 3-30 days, 4-4 months
Change of antibodies titers to herpes simplex viruses type 1 and 2
Detection of specific antibodies levels against herpes simplex virus (anti-HSV-1,2 IgM, anti-HSV-1,2 IgG) using ELISA in both groups
Measured: 2 points: before the start of therapy and on the 30th day after the start of therapy
Change of immune status parameters (flow cytometry)
Determination of changes of serum immunoglobulin levels by laser flow cytometry (g / l, UL): IgA, IgM, IgG, IgE total
Measured: 2 points: before treatment and at 30 days after initiation of therapy
Change of immune status parameters (flow cytometry)
Detection of changes of immune status parameters by laser flow cytometry (%): CD3+, CD4+, CD8+, CD4+/CD8+, CD16+, CD19+
Measured: 2 points: before treatment and at 30 days after initiation of therapy
Change of lymph nodes sizes (submandibular, axillary, inguinal) according to ultrasound data
Measured: 2 points: before and 6 months after the start of therapy
The assessment of quality of life according to questionnaire
Criteria for evaluating the "Quality of life" indicator were:
"excellent" - rashes and relapses of herpes simplex (HSV) are absent, physical and mental activity are above average, "good" - rare rashes of HSV (no more than 1-2 times per year), physical and mental activity are average, "satisfactory" - the rash of HSV were less likely (up to 3-4 times per year), physical and mental activity are below average, "has not changed" - the recurrence rate HSV for 6-12 months was same (as before the start of therapy and participation in the study), physical and mental activity are unsatisfactory.
Measured: up to 6 months after initiation of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start30 Oct 2017
- Primary completion29 Oct 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerpesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nearmedic Plus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georgy Vikulov, Ph.D, Principal investigator, Scientific Information Center for Prevention and Treatment of Viral Infections
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664127
- Sponsor's protocol ID
- version 1.0 from 20.10.2017
- Status last verified
- Jan 2019
- First submitted
- 27 Nov 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Immunological Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection) by Acyclic Nucleoside Valacyclovir and Interferon Inducer Kagocel
- ClinicalTrials.gov ID
- NCT04664127
- Acronym / sponsor ID
- version 1.0 from 20.10.2017
- Conditions
- Herpes, Herpes Simplex, Herpes Oral, Herpes Simplex 2, Herpes Genitalis
- Keywords
- herpes simplex, HSV1, HSV2, Herpes Genitalis, Herpes Oral, herpes simplex viruses, Valaciclovir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nearmedic Plus LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination therapy (Kagocel + Valacyclovir: n=25) | – | Drug: Kagocel+ValacyclovirTherapy according to routine practice (including Kagocel). Groups will be splitted during the final data analysis. |
| Monotherapy by Valacyclovir (n=20) | – | Drug: ValacyclovirTherapy according to routine practice. Groups will be splitted during the final data analysis. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men and women with signs of severe herpes simplex.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kagocel+ValacyclovirGroup 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 | Combination therapy (Kagocel + Valacyclovir: n=25) |
| ValacyclovirGroup 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. | Drug | Monotherapy by Valacyclovir (n=20) |
Primary outcome
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
Change of the rate of exacerbations of orolabial, genital and other localization herpes simplex
Time frame: 2 points: before and 6 months after the start of antiviral therapy
Change of the number of patients with varying degrees of severity illness
Time frame: 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
Time frame: up to 6 months
11 secondary outcomes
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)
Time frame: up to 6 (12) mounts
Change of the duration of each herpes simplex relapse and the rate of epithelialization
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 4 points: 1-before the start of therapy, 2-6 days after the start of therapy, 3-30 days, 4-4 months
Change in the number of herpes viruses in saliva and blood by PCR
Time frame: 4 points: 1-before the start of therapy, 2-6 days after the start of therapy, 3-30 days, 4-4 months
Change of antibodies titers to herpes simplex viruses type 1 and 2
Time frame: 2 points: before the start of therapy and on the 30th day after the start of therapy
Change of immune status parameters (flow cytometry)
Time frame: 2 points: before treatment and at 30 days after initiation of therapy
Change of immune status parameters (flow cytometry)
Time frame: 2 points: before treatment and at 30 days after initiation of therapy
Change of lymph nodes sizes (submandibular, axillary, inguinal) according to ultrasound data
Time frame: 2 points: before and 6 months after the start of therapy
The assessment of quality of life according to questionnaire
Time frame: up to 6 months after initiation of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Vikulov G., Voznesenskiy S. Сombination antiviral therapy of herpes simplex // Vrach. - 2019; 30 (5): 27-34. https://doi.org/10.29296/25877305-2019- 05-05Link provided by the sponsor.
- 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): 79-91Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgy Vikulov, Ph.D principal investigator
Scientific Information Center for Prevention and Treatment of Viral Infections
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes and Herpes Simplex, run by Nearmedic Plus LLC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.