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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Starpharma Pty Ltd
ClinicalTrials.gov Identifier:
NCT00740584
First received: August 21, 2008
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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: 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740584

Locations
Australia
Nucleus Network
Melbourne, Australia
Sponsors and Collaborators
Starpharma Pty Ltd
  More Information

Publications:
Responsible Party: Starpharma Pty Ltd
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Starpharma Pty Ltd:
Prevention

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Herpes Genitalis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 16, 2014