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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00442910

Run by

Starpharma Pty Ltd

People needed

61

Starts

2007-07-01

Expected to finish

2009-12-01

Last updated by the study team

2010-06-24

Who can join

Age: 18 and older, up to 24. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• HIV-uninfected
• General good health
• Normal Pap result within 12 months prior to study entry
• Predictable menstrual cycle with at least 21 days between menses
• Sexually active
• Willing to use effective methods of contraception for the duration of the study. More information on this criterion can be found in the protocol.
• Willing to abstain from oral-vaginal and penile-anal intercourse for the duration of the study
• Willing to not use other intravaginal products and/or devices for 72 hours prior to study entry through Week 3
• Agree to have partner use condoms provided by study for each act of intercourse during study participation
• Willing to undergo colposcopy if determined necessary by investigator
• Agree to not participate in other drug or device studies during study participation

You may not qualify if…

• History of adverse reaction to latex or to any component of the study products
• History of male sex partner having an allergic reaction to latex
• Any abnormal finding on physical or pelvic examination
• Sexually transmitted infection (STI) or reproductive tract infection. More information on this criterion is available in the protocol.
• Diagnosed with STI within 6 months prior to study entry
• Use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to study entry
• Gynecological surgical procedure within 90 days prior to study entry
• Certain abnormal laboratory values. More information on this criterion is available in the protocol.
• Received non-therapeutic intravenous drugs within 12 months prior to study entry
• Any social or medical condition, that, in the opinion of the investigator, would interfere with the study
• Pregnant of breastfeeding

Where it is running

• University of South Florida — Tampa, Florida, United States
• Center for Family Planning Research, Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States
• University of Puerto Rico — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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