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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections HSV-2 Genital Herpes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label, only arm

3%w/w SPL7013 vaginal gel (VivaGel)

Group Type EXPERIMENTAL

3% SPL7013 Gel (VivaGel)

Intervention Type DRUG

A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days.

Interventions

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3% SPL7013 Gel (VivaGel)

A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes