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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00740584
Recruitment Status : Completed
First Posted : August 25, 2008
Results First Posted : August 14, 2012
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Starpharma Pty Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections HSV-2 Genital Herpes Drug: 3% SPL7013 Gel (VivaGel) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Local Retention and Duration of Activity of SPL7013 Following Vaginal Application of 3% SPL7013 Gel (VivaGel) in Healthy Volunteers
Study Start Date : August 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Label, only arm
3%w/w SPL7013 vaginal gel (VivaGel)
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740584


Locations
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Australia
Nucleus Network
Melbourne, Australia
Sponsors and Collaborators
Starpharma Pty Ltd
National Institute of Allergy and Infectious Diseases (NIAID)
More Information
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Publications:

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Responsible Party: Starpharma Pty Ltd
ClinicalTrials.gov Identifier: NCT00740584    
Other Study ID Numbers: SPL7013-003
NIH contract HHSN266200500042C
DAIDS ES number 10730
First Posted: August 25, 2008    Key Record Dates
Results First Posted: August 14, 2012
Last Update Posted: October 30, 2018
Last Verified: October 2018
Keywords provided by Starpharma Pty Ltd:
Prevention
Additional relevant MeSH terms:
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Herpes Genitalis
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Virus Diseases
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections