A Study to Investigate the Efficacy, Safety and Tolerability of PEG in Patients With Genital Herpes
Phase 2
Terminated
- Conditions
- Genital Herpes
- Interventions
- Drug: PEG-Formulation
- Registration Number
- NCT01765114
- Lead Sponsor
- Devirex AG
- Brief Summary
The aim of this study is therefore to investigate the efficacy of the PEG-formulation to reduce the frequency and duration of genital herpes recurrences, to assess its safety and tolerability and to investigate its effect on shedding.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Informed Consent
- 18 - 65 years
- Positive for HSV-1 and/or -2 (as determined by serology testing in course of study)
- Initial infection > 1 year ago
- ≥ 6 recurrences in the last year (or in the year prior to a recent prophylactic therapy)
- ≥ 2 recurrences during the six-month baseline period
Exclusion Criteria
- Known or suspected allergy or intolerability to PEG
- Prophylactic antiviral drugs, virostatic agents, cytostatics, immunomodulatory drugs and steroids within less than 14 days prior to baseline period, or plan to take such drugs during the trial
- Pregnancy and/or breast-feeding
- History of malignant diseases (described in chapter 7.2)
- Known or suspected non-compliance to study protocol
- Participation in another investigational drug study in the last 30 days prior to baseline period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PEG-Formulation PEG-Formulation PEG-Formulation, applied twice daily during the treatment period (duration: 6 months)
- Primary Outcome Measures
Name Time Method Change of number of genital herpes recurrences during the treatment period as compared to the baseline period. Baseline and Treatment period (6 months each). The number of genital herpes recurrences will be counted during the baseline period (6 months) and during the treatment period (6 months) and then be compared.
- Secondary Outcome Measures
Name Time Method The safety of the PEG-formulation via reporting of AEs. Baseline and Treatment period (6 months each).
Trial Locations
- Locations (1)
University Hospital Zurich
🇨🇭Zurich, Switzerland