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

Devirex

Status and phase: Terminated; Phase 2

Conditions: Genital Herpes

Treatments: Drug: PEG-Formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01765114

DEV-PEG-02

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

PEG-Formulation

Experimental group

Description:

PEG-Formulation, applied twice daily during the treatment period (duration: 6 months)

Treatment:

Drug: PEG-Formulation