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

HIV Infections Clinical Trial

Official title:

Assessment of Local Retention and Duration of Activity of SPL7013 Following Vaginal Application of 3% SPL7013 Gel (VivaGel) in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740584
• Other study ID #: SPL7013-003
• Secondary ID: NIH contract HHS
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2018
• Source: Starpharma Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Herpes Genitalis
• HIV Infections
• HSV-2 Genital Herpes

Intervention

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.

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne

Sponsors (2)

Lead Sponsor	Collaborator
Starpharma Pty Ltd	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)	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.	at 3 hours
Secondary	Number of Participants With Adverse Experiences	Number of participants with any untoward medical occurrence in a subject administered the Investigational Product, irrespective of any perceived causality to that study product	Approximately 13 weeks