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

Phase 1

Completed

• Conditions: HSV-2 Genital Herpes; HIV Infections
• Interventions: Drug: 3% SPL7013 Gel (VivaGel)

• Registration Number: NCT00740584
• Lead Sponsor: Starpharma Pty Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-21
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-25
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2012-04-03
• Results First Submitted QC: 2012-07-05
• Results First Posted: 2012-08-14
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label, only arm	3% SPL7013 Gel (VivaGel)	3%w/w SPL7013 vaginal gel (VivaGel)

Primary Outcome Measures

Name	Time	Method
HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)	at 3 hours	The HIV antiviral activity is the ability of each sample taken from the vagina (cervico-vaginal (CV) sample) to inhibit HIV virus from infecting a specific cell culture.; The inhibition of HIV in the presence of the CV sample is compared to the inhibition of HIV in the cell culture with no CV sample added. This allows an assessment of the affect that the CV sample has.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Experiences	Approximately 13 weeks	Number of participants with any untoward medical occurrence in a subject administered the Investigational Product, irrespective of any perceived causality to that study product

Trial Locations

Locations (1)

Nucleus Network; 🇦🇺 Melbourne, Australia