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A Study to Investigate the Efficacy, Safety and Tolerability of PEG in Patients With Genital Herpes

This study is currently recruiting participants.
Verified April 2013 by Devirex AG
Sponsor:
Information provided by (Responsible Party):
Devirex AG
ClinicalTrials.gov Identifier:
NCT01765114
First received: December 14, 2012
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Genital Herpes
 Drug: PEG-Formulation
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Open-label, Intra-individual Controlled, Single-center Study to Investigate the Efficacy, Safety and Tolerability of a Polyethylene Glycol-formulation and the Viral Shedding in Patients Suffering From Genital Herpes

Resource links provided by NLM:

MedlinePlus related topics: Genital Herpes
U.S. FDA Resources

Further study details as provided by Devirex AG:

Primary Outcome Measures:
  • Change of number of genital herpes recurrences during the treatment period as compared to the baseline period. [ Time Frame: Baseline and Treatment period (6 months each). ] [ Designated as safety issue: No ]
    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:
  • The safety of the PEG-formulation via reporting of AEs. [ Time Frame: Baseline and Treatment period (6 months each). ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • The frequency of days with viral shedding which will be analysed by quantitative PCR. [ Time Frame: Baseline and Treatment period (6 months each). ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG-Formulation
PEG-Formulation, applied twice daily during the treatment period (duration: 6 months)
 Drug: PEG-Formulation

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765114

Contacts
Contact: Thomas Kuendig, MD +41 (0)44 255 39 73 thomas.kuendig@usz.ch
Contact: Fabian Tay, MD +41 (0)44 255 11 11 fabian.tay@usz.ch

Locations
Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Principal Investigator: Thomas Kuendig, MD            
Sponsors and Collaborators
Devirex AG
Investigators
Principal Investigator: Thomas Kuendig, MD University of Zurich
  More Information

No publications provided

Responsible Party: Devirex AG
ClinicalTrials.gov Identifier: NCT01765114     History of Changes
Other Study ID Numbers: DEV-PEG-02
Study First Received: December 14, 2012
Last Updated: April 2, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013