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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

August 21, 2008
July 5, 2012
August 2008
March 2009   (final data collection date for primary outcome measure)
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.

HIV and HSV-2 Antiviral activity and amount of SPL7013 [ Time Frame: Over 24 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00740584 on ClinicalTrials.gov Archive Site
Incidence of Adverse Experiences [ Time Frame: Approximately 13 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.
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.

Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • HSV-2 Genital Herpes
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.
Experimental: Open Label, only arm
3%w/w SPL7013 vaginal gel (VivaGel)
Intervention: Drug: 3% SPL7013 Gel (VivaGel)
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. doi: 10.1371/journal.pone.0024095. Epub 2011 Sep 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00740584
SPL7013-003, NIH contract HHSN266200500042C, DAIDS ES number 10730
No
Starpharma Pty Ltd
Starpharma Pty Ltd
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Starpharma Pty Ltd
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP