NCT01281007

Brief Summary

Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms, such as famciclovir and aciclovir. This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with famciclovir (125 mg) versus aciclovir (200 mg) in patients with active recurrent genital herpes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2012

Typical duration for phase_3

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

July 7, 2015

Completed
Last Updated

April 21, 2021

Status Verified

July 1, 2015

Enrollment Period

2.5 years

First QC Date

January 20, 2011

Results QC Date

May 29, 2015

Last Update Submit

March 30, 2021

Conditions

GENITAL HERPES

Keywords

Herpes Simplex Virus

Outcome Measures

Primary Outcomes (1)

  • Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation

    Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.

    Day 5

Secondary Outcomes (1)

  • Safety Will be Evaluated by the Adverse Events Occurence

    Day 5

Study Arms (2)

Famciclovir 125 mg

EXPERIMENTAL

1 tablet every 12 hours for 5 days

Drug: Famciclovir

Aciclovir 200 mg

ACTIVE COMPARATOR

1 tablet every 4 hours (excluding nocturnal dose) for 5 days

Drug: Aciclovir

Interventions

FamciclovirDRUG

Famciclovir 125 mg every 12 hours for 5 days

Famciclovir 125 mg
AciclovirDRUG

Aciclovir 200 mg every 4 hours fo 5 days

Aciclovir 200 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be able to understand the study procedures agree to participate and give written consent.
  • Patients with clinical diagnosis of recurrent genital herpes;
  • Score symptoms higher than 4;
  • Negative pregnant urine test.

You may not qualify if:

  • Pregnancy or risk of pregnancy.
  • Lactation
  • Any pathology or past medical condition that can interfere with this protocol.
  • Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study);
  • Patients with immunodeficiency and/or immunosuppressive disease;
  • Hypersensitivity to components of the formula;
  • Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

SPVita

Bragança Paulista, São Paulo, Brazil

Location

Caep Centro Avancado de Estudos E Pesquisas Ltda

Campinas, São Paulo, Brazil

Location

CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas

Campinas, São Paulo, Brazil

Location

CECIP - Centro de Estudos Clínicos do Interior Paulista

Jaú, São Paulo, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

Instituto Sirio Libanes de Ensino e Pesquisa

São Paulo, São Paulo, 01308-060, Brazil

Location

Afip - Associacao Fundo de Incentivo A Psicofarmacologia

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Herpes GenitalisHerpes Simplex

Interventions

FamciclovirAcyclovir

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleMale Urogenital DiseasesSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGuanineHypoxanthinesPurinones

Results Point of Contact

Title
Manager of Clinical Trials
Organization
EMS
pesquisa.clinica@ems.com.br
+5501938874176

Study Officials

  • Roberto Amazonas, MD

    EMS

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2011

First Posted

January 21, 2011

Study Start

July 1, 2012

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

April 21, 2021

Results First Posted

July 7, 2015

Record last verified: 2015-07

Locations

BR(9)