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

Primary Purpose

HIV Infections, HSV-2 Genital Herpes

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
3% SPL7013 Gel (VivaGel)
Sponsored by
Starpharma Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Prevention

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Nucleus Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label, only arm

Arm Description

3%w/w SPL7013 vaginal gel (VivaGel)

Outcomes

Primary Outcome Measures

HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)
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

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

Full Information

First Posted
August 21, 2008
Last Updated
October 1, 2018
Sponsor
Starpharma Pty Ltd
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00740584
Brief Title
Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.
Official Title
Assessment of Local Retention and Duration of Activity of SPL7013 Following Vaginal Application of 3% SPL7013 Gel (VivaGel) in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Starpharma Pty Ltd
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HSV-2 Genital Herpes
Keywords
Prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label, only arm
Arm Type
Experimental
Arm Description
3%w/w SPL7013 vaginal gel (VivaGel)
Intervention Type
Drug
Intervention Name(s)
3% SPL7013 Gel (VivaGel)
Intervention Description
A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days.
Primary Outcome Measure Information:
Title
HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)
Description
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.
Time Frame
at 3 hours
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Experiences
Description
Number of participants with any untoward medical occurrence in a subject administered the Investigational Product, irrespective of any perceived causality to that study product
Time Frame
Approximately 13 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Nucleus Network
City
Melbourne
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
21935377
Citation
Price CF, Tyssen D, Sonza S, Davie A, Evans S, Lewis GR, Xia S, Spelman T, Hodsman P, Moench TR, Humberstone A, Paull JR, Tachedjian G. SPL7013 Gel (VivaGel(R)) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans. PLoS One. 2011;6(9):e24095. doi: 10.1371/journal.pone.0024095. Epub 2011 Sep 15.
Results Reference
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Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.

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