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

This study has been completed.

First Received on August 21, 2008. Last Updated on June 9, 2011 History of Changes

Sponsor:	Starpharma Pty Ltd
Collaborator:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	Starpharma Pty Ltd
ClinicalTrials.gov Identifier:	NCT00740584

Purpose

To assess the retention and anti-viral activity (HIV and 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 I Phase II

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Genital Herpes HIV/AIDS

Drug Information available for: SPL 7013

U.S. FDA Resources

Further study details as provided by Starpharma Pty Ltd:

Primary Outcome Measures:

HIV and HSV-2 Antiviral activity and amount of SPL7013 [ Time Frame: Over 24 hours ] [ Designated as safety issue: No ]

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

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

Locations

Australia
Nucleus Network
Melbourne, Australia

Sponsors and Collaborators

Starpharma Pty Ltd

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

No publications provided by Starpharma Pty Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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®) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans. PLoS One. 2011;6(9):e24095. Epub 2011 Sep 15.

Responsible Party:	Dr Peter Hodsman, Nucleus Network
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
Last Updated:	June 9, 2011
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 February 21, 2012