Phase 2
N=12
Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.
HIV Infections · HSV-2 Genital Herpes
Bottom Line
View on ClinicalTrials.gov: NCT00740584 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup) — 96 percent anti-viral activity
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 3% SPL7013 Gel (VivaGel) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Starpharma Pty Ltd
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup) |
96 | — |
| SECONDARY Number of Participants With Adverse Experiences |
7 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00740584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.