Status:
COMPLETED
Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women
Lead Sponsor:
Starpharma Pty Ltd
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Healthy
Eligibility:
FEMALE
18-24 years
Phase:
PHASE1
Brief 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 s...
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 preve...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00442910
Start Date
July 1 2007
End Date
December 1 2009
Last Update
June 24 2010
Active Locations (3)
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1
University of South Florida
Tampa, Florida, United States, 33606
2
Center for Family Planning Research, Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213-3180
3
University of Puerto Rico
San Juan, Puerto Rico, 00936-5067