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

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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

Tracking Information
First Submitted Date  ICMJE August 21, 2008
First Posted Date  ICMJE August 25, 2008
Results First Submitted Date  ICMJE April 3, 2012
Results First Posted Date  ICMJE August 14, 2012
Last Update Posted Date October 30, 2018
Study Start Date  ICMJE August 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2008)
HIV and HSV-2 Antiviral activity and amount of SPL7013 [ Time Frame: Over 24 hours ]
Change History Complete list of historical versions of study NCT00740584 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2008)
Incidence of Adverse Experiences [ Time Frame: Approximately 13 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.
Official Title  ICMJE Assessment of Local Retention and Duration of Activity of SPL7013 Following Vaginal Application of 3% SPL7013 Gel (VivaGel) in Healthy Volunteers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • HSV-2 Genital Herpes
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Open Label, only arm
3%w/w SPL7013 vaginal gel (VivaGel)
Intervention: Drug: 3% SPL7013 Gel (VivaGel)
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2008)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00740584
Other Study ID Numbers  ICMJE SPL7013-003
NIH contract HHSN266200500042C
DAIDS ES number 10730
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Starpharma Pty Ltd
Study Sponsor  ICMJE Starpharma Pty Ltd
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE Not Provided
PRS Account Starpharma Pty Ltd
Verification Date October 2018

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