Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00740584|
Recruitment Status : Completed
First Posted : August 25, 2008
Results First Posted : August 14, 2012
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections HSV-2 Genital Herpes||Drug: 3% SPL7013 Gel (VivaGel)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Local Retention and Duration of Activity of SPL7013 Following Vaginal Application of 3% SPL7013 Gel (VivaGel) in Healthy Volunteers|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
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.
- 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.
- Incidence of Adverse Experiences [ Time Frame: Approximately 13 weeks ]Any untoward medical occurrence in a subject administered the Investigational Product, irrespective of any perceived causality to that study product
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740584