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Trial record 28 of 112 for:    acyclovir

Melatonin Effects on Genital Herpes in Brazilian Women

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ClinicalTrials.gov Identifier: NCT03831165
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
Genital herpes is a common and increasingly-common infection worldwide. The annual incidence in the United States is 1.75 per 1000 inhabitants. The etiologic agent is the herpes type 1 and 2 strains simplex virus. Classical Treatment is with acyclovir which decreases the duration of the disease and prevents rashes but has no curative effect. Also, studies show herpes resistance to acyclovir which has stimulating research into new drugs to treat this condition. Authors suggest melatonin way be a therapeutic agent in herpetic disease due to its modulatory action in immune and inflammatory responses when administered in adequate doses. Therefore, the aim of this study is to evaluate the effects of melatonin in the treatment of genital herpes as well as compare it to acyclovir in a double-blind, prospective and randomized, investigation. Outcame measures will include clinical evaluation of patients and laboratory endpoints.

Condition or disease Intervention/treatment Phase
Genital Herpes Combination Product: Melatonin Drug: Acyclovir 400 MG Phase 4

Detailed Description:
The authors have investigate the relationship of estrogen-dependent malignant tumors with reduced levels of melatonin. It is speculated that the indoleamine can be classified as anti-estrogenic drug, both by its action on estrogen synthesis with aromatase inhibition and by its interference with estrogen receptors. Experimentally melatonin prevents promotion and growth of mammary tumors in rodents, probably by interacting with epithelial cell receptor; increasing local immunity by acting as an antioxidant agent and by inhibiting telomerase activity intumor cells .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The patients will be divided into three groups. One group (group A) will receive a bottle with 360 pills of acyclovir 200 mg. These individuals will be instructed to take 2 tablets of 200mg acyclovir (400 mg) twice daily for 90 days. Group B will receive 90 tablets of 30 mg of melatonin, the tablet will be used as 01 tablet daily for 90 days. Group C will receive 90 tablets of melatonin 3mg, and 360 tablets of acyclovir dose is 1 tablet per day for 90 days.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The patients will be treated at the Clinic of Gynecology, USP during a total of 04 visits. In the first and fourth visits, patients will be sent to the laboratory of the University Hospital for collecting the CD4 +, interleukin-2 and serology for herpes.
Primary Purpose: Treatment
Official Title: Effects of Melatonin in the Treatment of Genital Herpes
Actual Study Start Date : September 2, 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Herpes

Arm Intervention/treatment
Experimental: melatonin 3mg + Acyclovir 400mg
GI - melatonin 3mg + Acyclovir 400mg
Combination Product: Melatonin
The volunteers will receive information about the study and sign the free and informed consent form (ICF). After, will be delivered bottle identified by letters (abc, bca or cab) with its drug without patient and investigator know its nature. It will only be revealed which drug was used by every woman at the end of the study; but occurring worsening of herpetic disease, the blind will be broken for proper assessment of the participant. If the employee drug is melatonin, this case will be considered as therapeutic failure in the final statistical analysis.
Other Name: placebo

Drug: Acyclovir 400 MG
These individuals will be instructed to take 2 tablets of 200mg acyclovir (400 mg) twice daily for 90 days

Active Comparator: Acyclovir 400mg
GII - Acyclovir 400mg twice a day
Combination Product: Melatonin
The volunteers will receive information about the study and sign the free and informed consent form (ICF). After, will be delivered bottle identified by letters (abc, bca or cab) with its drug without patient and investigator know its nature. It will only be revealed which drug was used by every woman at the end of the study; but occurring worsening of herpetic disease, the blind will be broken for proper assessment of the participant. If the employee drug is melatonin, this case will be considered as therapeutic failure in the final statistical analysis.
Other Name: placebo

Drug: Acyclovir 400 MG
These individuals will be instructed to take 2 tablets of 200mg acyclovir (400 mg) twice daily for 90 days

Placebo Comparator: placebo + melatonin 3mg
GIII - placebo + melatonin 3mg
Combination Product: Melatonin
The volunteers will receive information about the study and sign the free and informed consent form (ICF). After, will be delivered bottle identified by letters (abc, bca or cab) with its drug without patient and investigator know its nature. It will only be revealed which drug was used by every woman at the end of the study; but occurring worsening of herpetic disease, the blind will be broken for proper assessment of the participant. If the employee drug is melatonin, this case will be considered as therapeutic failure in the final statistical analysis.
Other Name: placebo

Drug: Acyclovir 400 MG
These individuals will be instructed to take 2 tablets of 200mg acyclovir (400 mg) twice daily for 90 days




Primary Outcome Measures :
  1. Recrutining pacients [ Time Frame: 1 year ]
    Patients will be recruited in the Clinic, Department of Gynecology, Hospital das Clinicas, Faculty of Medicine, University of São Paulo



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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female only
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • clinical and laboratory diagnosis of genital herpes
  • real time PCR
  • serology

Exclusion criteria:

  • immunodeficiencies
  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831165


Contacts
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Contact: Cristiane L Roa, MD 5511 999931311 cristianeroa@hotmail.com
Contact: Jose M Soares Junior, PhD 5511 982075781 jsoares415@hotmail.com

Locations
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Brazil
Avenida Doutor Eneas Carvalho de Aguiar 255 10 andar Recruiting
São Paulo, SP, Brazil, 05403000
Contact: Jose M Soares Junior, PhD    5511 982075781    jsoares415@hotmail.com   
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo Recruiting
Sao Paulo, Brazil, 05403000
Contact: Jose M Soares Junior, PhD    551126617621    jsoares415@hotmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Director: Edmund C Baracat, PhD Universidade de Sao Paulo General Hospital

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03831165     History of Changes
Other Study ID Numbers: 1215208
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Sao Paulo General Hospital:
acyclovir
melatonin

Additional relevant MeSH terms:
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Acyclovir
Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Antiviral Agents
Anti-Infective Agents