skip to content

Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Starpharma Pty Ltd

Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

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
History of Changes
Purpose

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: 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

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 45 Years  
Sexes 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

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
National Institute of Allergy and Infectious Diseases (NIAID)
More Information

More Information


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  
Last Updated: July 5, 2012  

Keywords provided by Starpharma Pty Ltd:

Prevention

Additional relevant MeSH terms:
HIV Infections
Herpes Genitalis

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.