CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
3% SPL7013 Gel (VivaGel)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00740584
NCT00740584Phase 2Completed
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Assessment of Local Retention and Duration of Activity of SPL7013 Following Vaginal Application of 3% SPL7013 Gel (VivaGel) in Healthy Volunteers

Starpharma Pty Ltd·interventional·Posted Aug 25, 2008·Updated Oct 30, 2018

In Brief

A Phase 2 clinical trial evaluating 3% SPL7013 Gel (VivaGel) for HIV Infections and HSV-2 Genital Herpes. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, HSV-2 Genital Herpes
CountriesAustralia
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 25, 2008
Enrollment StartAug 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.9 years ago

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.