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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
61
3% vaginal gel
Placebo for SPL7013 gel
HEC Placebo gel intravaginally bd for 14 days
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
Incidence of abnormal genital symptoms and/or pelvic exam findings
Time frame: Throughout study
Occurrence of adverse events and/or abnormal laboratory values
Time frame: Throughout study
Changes in vaginal microflora
Time frame: Throughout study
Proportion of participants who report an 80% or greater adherence rate
Time frame: At Day 7 and Day 14
Proportion of participants who say they would be very likely to use the study product in the future
Time frame: At Day 14
Reported positive and negative aspects of using study product
Time frame: Throughout study
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