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

Genital Herpes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01765114
• Other study ID #: DEV-PEG-02
• Status: Terminated
• Phase: Phase 2
• First received: December 14, 2012
• Last updated: August 4, 2014
• Start date: February 2013
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Devirex AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Genital Herpes
• Herpes Genitalis

Intervention

Drug:
• PEG-Formulation

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Devirex AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The frequency of days with viral shedding which will be analysed by quantitative PCR.		Baseline and Treatment period (6 months each).	No
Primary	Change of number of genital herpes recurrences during the treatment period as compared to the baseline period.	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.	Baseline and Treatment period (6 months each).	No
Secondary	The safety of the PEG-formulation via reporting of AEs.		Baseline and Treatment period (6 months each).	Yes