Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up to 24 hours after administration of 3% SPL7013 in the vagina. There is no hypothesis for this study.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Starpharma Pty Ltd
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

Inclusion Criteria:

• Healthy women aged 18-45 with regular menstrual cycles, free from sexually transmitted infections and using adequate contraception

Exclusion Criteria:

• Any condition, including genital conditions, sexually transmitted infection, menopause, and/or allergies that would make the study participant unsuitable for the study.

• Pregnancy or breast-feeding