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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01765114

Enrollment

Registered

2013-01-10

Start date

2013-02-28

Completion date

2014-08-31

Last updated

2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genital Herpes

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.

Interventions

DRUGPEG-Formulation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
The safety of the PEG-formulation via reporting of AEs.	Baseline and Treatment period (6 months each).

Other

Measure	Time frame
The frequency of days with viral shedding which will be analysed by quantitative PCR.	Baseline and Treatment period (6 months each).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026