GENITAL HERPES
Conditions
Keywords
Herpes Simplex Virus
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.
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
Interventions
DRUGFamciclovir
Famciclovir 125 mg every 12 hours for 5 days
DRUGAciclovir
Aciclovir 200 mg every 4 hours fo 5 days
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must be able to understand the study procedures agree to participate and give written consent. 2. Patients with clinical diagnosis of recurrent genital herpes; 3. Score symptoms higher than 4; 4. Negative pregnant urine test.
Exclusion criteria
1. Pregnancy or risk of pregnancy. 2. Lactation 3. Any pathology or past medical condition that can interfere with this protocol. 4. Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study); 5. Patients with immunodeficiency and/or immunosuppressive disease; 6. Hypersensitivity to components of the formula; 7. Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation | Day 5 | Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Will be Evaluated by the Adverse Events Occurence | Day 5 | Adverse events will be collected and followed in order to evaluate safety and tolerability |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Famciclovir 125 mg 1 tablet every 12 hours for 5 days
Famciclovir: Famciclovir 125 mg every 12 hours for 5 days | 75 |
| Aciclovir 200 mg 1 tablet every 4 hours (excluding nocturnal dose) for 5 days
Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days | 75 |
| Total | 150 |
Baseline characteristics
| Characteristic | Famciclovir 125 mg | Aciclovir 200 mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 73 Participants | 143 Participants |
| Region of Enrollment Brazil | 75 participants | 75 participants | 150 participants |
| Sex: Female, Male Female | 57 Participants | 50 Participants | 107 Participants |
| Sex: Female, Male Male | 18 Participants | 25 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 75 | 12 / 75 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 |
Outcome results
Primary
Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation
Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
Time frame: Day 5
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Famciclovir 125 mg | Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation | 73 subjects |
| Aciclovir 200 mg | Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation | 52 subjects |
Secondary
Safety Will be Evaluated by the Adverse Events Occurence
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time frame: Day 5