NCT00442910

Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women

Phase 1 Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Starpharma Pty Ltd · Industry
• Sex: Female
• Age: 18 Years – 24 Years
• Healthy volunteers: Accepted

Summary

There is an urgent need for HIV prevention methods that women can initiate and control themselves. Topical microbicides, substances that kill microbes, represent one such method. The purpose of this study is to assess the safety and to evaluate the acceptability of 3% w/w SPL7013 gel, a topical microbicide, when administered intravaginally for 14 consecutive days in healthy, sexually active HIV uninfected women.

Detailed description

Women continue to comprise a growing proportion of the new HIV infections around the world. A growing body of data suggests that a safe and effective topical microbicide will be a real option of prevention for women in the future. The purpose of this study is to assess the safety and acceptability of 3% SPL7013 Gel when administered intravaginally, twice daily for 14 consecutive days in healthy, sexually-active, HIV-uninfected women. The expected duration of this study for each participant is 21 days. Study participants will be randomly assigned to one of two arms. Participants in Arm 1 will apply 3.5 g of SPL7013 gel intravaginally twice daily for 14 consecutive days. Participants in Arm 2 will apply a placebo gel intravaginally twice daily for 14 consecutive days. Starpharma produces SPL7013 gel (VivaGel) and will provide it for this study. After enrollment, participants will attend three study visits. These visits will occur on Days 7, 14, and 21. A follow-up safety visit will occur if necessary. Medical and menstrual history, targeted physical exam, urine and blood collection, cervical swabs, and vaginal smears will occur at all visits. A colposcopy will occur at least once. On Day 2, participants will take part in a phone assessment.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	3% SPL7013 Gel (VivaGel)	3% vaginal gel
DRUG	Placebo Gel	Placebo for SPL7013 gel
DRUG	HEC Placebo Gel	HEC Placebo gel intravaginally bd for 14 days

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2007-03-05
• Last updated: 2010-06-24

Locations

3 sites across 2 countries: United States, Puerto Rico