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

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Devirex AG

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