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

This study has been completed.
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Starpharma Pty Ltd Identifier:
First received: August 21, 2008
Last updated: July 5, 2012
Last verified: July 2012
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 Intervention Phase
HIV Infections HSV-2 Genital Herpes Drug: 3% SPL7013 Gel (VivaGel) Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Starpharma Pty Ltd:

Primary Outcome Measures:
  • 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:
  • Incidence of Adverse Experiences [ Time Frame: Approximately 13 weeks ]

Enrollment: 12
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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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Please refer to this study by its identifier: NCT00740584

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

Responsible Party: Starpharma Pty Ltd Identifier: NCT00740584     History of Changes
Other Study ID Numbers: SPL7013-003
NIH contract HHSN266200500042C
DAIDS ES number 10730
Study First Received: August 21, 2008
Results First Received: April 3, 2012
Last Updated: July 5, 2012

Keywords provided by Starpharma Pty Ltd:

Additional relevant MeSH terms:
HIV Infections
Herpes Genitalis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Genital Diseases, Male
Genital Diseases, Female processed this record on September 21, 2017