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

October 1, 2018 updated by: Starpharma Pty Ltd

Assessment of Local Retention and Duration of Activity of SPL7013 Following Vaginal Application of 3% SPL7013 Gel (VivaGel) in Healthy Volunteers

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Melbourne, Australia
        • Nucleus Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Label, only arm
3%w/w SPL7013 vaginal gel (VivaGel)
A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)
Time Frame: 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.

at 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Experiences
Time Frame: 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
Approximately 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 21, 2008

First Submitted That Met QC Criteria

August 21, 2008

First Posted (Estimate)

August 25, 2008

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SPL7013-003
  • NIH contract HHSN266200500042C
  • DAIDS ES number 10730

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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