Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.
This study has been completed.
Sponsor:
Starpharma Pty Ltd
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
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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: 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 |
Resource links provided by NLM:
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 ] [ 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.
Secondary Outcome Measures:
- Incidence of Adverse Experiences [ Time Frame: Approximately 13 weeks ] [ Designated as safety issue: Yes ]
| 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| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders 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 More Information
Publications:
| 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 |
| Results First Received: | April 3, 2012 |
| Last Updated: | July 5, 2012 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Starpharma Pty Ltd:
|
Prevention |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Herpes Genitalis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Herpes Simplex Herpesviridae Infections DNA Virus Infections Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013