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

NCT00740584 | Completed Phase 1 Results

• 3 other identifiers: SPL7013-003NIH contract HHSN266200500042CDAIDS ES number 10730
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; HSV-2 Genital Herpes

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Adverse Experiences

  Approximately 13 weeks

Study Arms (1)

Open Label, only arm

EXPERIMENTAL

3%w/w SPL7013 vaginal gel (VivaGel)

Drug: 3% SPL7013 Gel (VivaGel)

Interventions

3% SPL7013 Gel (VivaGel) DRUG

A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days.

Open Label, only arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women aged 18-45 with regular menstrual cycles, free from sexually transmitted infections and using adequate contraception

You may not qualify if:

• 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

Sponsors & Collaborators

• Starpharma Pty Ltd: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Nucleus Network

Melbourne, Australia

Location

Related 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(R)) 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.

  PMID: 21935377 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

astodrimer

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Clinical Development Manger
• Organization: Starpharma Pty Ltd

clare.price@starpharma.com

+61 3 9532 2700

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 25, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 30, 2018
• Results First Posted: August 14, 2012

Record last verified: 2018-10

Locations

AU (1)