GENITAL HERPESPhase 3NCT01281007
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
A Phase 3 study testing Famciclovir and Aciclovir in people with GENITAL HERPES, run by EMS at 9 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GENITAL HERPES
- What is being tested?
- Famciclovir and Aciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesBrazil
- Study dates
- Jul 2012to Mar 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Brazil9 sites
SPVita
Bragança Paulista, São Paulo
Caep Centro Avancado de Estudos E Pesquisas Ltda
Campinas, São Paulo
CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas
Campinas, São Paulo
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda
Porto Alegre, Rio Grande do Sul
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, São Paulo, 14048900
Instituto Sirio Libanes de Ensino e Pesquisa
São Paulo, São Paulo, 01308-060
Afip - Associacao Fundo de Incentivo A Psicofarmacologia
São Paulo, São Paulo
About this study
Official title: A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Famciclovir 125 mg Comparing to Aciclovir 200 mg in Patients With Active Recurrent Genital Herpes
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.
Read the detailed description
STUDY DESIGN
- Open-label, prospective, parallel group, intent to treat trial
- Experiment duration: 5 days
- 2 visits (days 1, and 5)
- Reduction of symptoms
- Adverse events evaluation
- Conditions
- GENITAL HERPES
- Being tested
- Famciclovir, Aciclovir
- Keywords
- Herpes Simplex Virus
- Medical subject headings
- Herpes Genitalis, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamciclovirDrug
Famciclovir 125 mg every 12 hours for 5 days
AciclovirDrug
Aciclovir 200 mg every 4 hours fo 5 days
| Study group | Role | What they receive |
|---|---|---|
| Famciclovir 125 mg | Experimental | 1 tablet every 12 hours for 5 days Receives: Drug: Famciclovir |
| Aciclovir 200 mg | Active comparator | 1 tablet every 4 hours (excluding nocturnal dose) for 5 days Receives: Drug: Aciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation
Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
Measured: Day 5
Secondary outcomes (1)
Safety Will be Evaluated by the Adverse Events Occurence
Adverse events will be collected and followed in order to evaluate safety and tolerability
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startJul 2012
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GENITAL HERPESStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roberto Amazonas, MD, Study director, EMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281007
- Sponsor's protocol ID
- F125EMS1010
- Status last verified
- Jul 2015
- First submitted
- 20 Jan 2011
- Last updated
- 21 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Famciclovir 125 mg Comparing to Aciclovir 200 mg in Patients With Active Recurrent Genital Herpes
- ClinicalTrials.gov ID
- NCT01281007
- Acronym / sponsor ID
- F125EMS1010
- Conditions
- GENITAL HERPES
- Keywords
- Herpes Simplex Virus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Posted 7 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
STUDY DESIGN
- Open-label, prospective, parallel group, intent to treat trial
- Experiment duration: 5 days
- 2 visits (days 1, and 5)
- Reduction of symptoms
- Adverse events evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Famciclovir 125 mg | Experimental | Drug: Famciclovir1 tablet every 12 hours for 5 days |
| Aciclovir 200 mg | Active comparator | Drug: Aciclovir1 tablet every 4 hours (excluding nocturnal dose) for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| FamciclovirFamciclovir 125 mg every 12 hours for 5 days | Drug | Famciclovir 125 mg |
| AciclovirAciclovir 200 mg every 4 hours fo 5 days | Drug | Aciclovir 200 mg |
Primary outcome
Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation
Time frame: Day 5
Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
1 secondary outcome
Safety Will be Evaluated by the Adverse Events Occurence
Time frame: Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Roberto Amazonas, MD study director
EMS
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Famciclovir and Aciclovir in people with GENITAL HERPES, run by EMS at 9 sites in Brazil.
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 4 inclusion and 7 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 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation (time frame: Day 5). 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 21 Apr 2021.