Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease-causing agents. In the future, topical microbicides may be applied vaginally to prevent both acquisition and transmission of HIV and other sexually transmitted infections (STIs). The purpose of this study is to assess whether there is a measurable response to daily applications of a topical microbicide, 1% tenofovir gel, in women at low risk for HIV infection.
A new approach to HIV prevention currently being studied is the use of topical microbicides. This study will measure the mucosal response to daily intravaginal applications of 1% tenofovir gel versus placebo in two groups of women at low risk for HIV infection. The duration of this study for each participant is 21 days. Study participants will be randomly assigned to one of two study groups. Group 1 participants will apply 1% tenofovir gel daily for 14 consecutive days between menses. Group 2 participants will apply placebo gel for 14 consecutive days between menses. Study visits will occur on Days 3, 7, 14, and 21. Study entry will occur 2 to 6 days following the menses and within 30 days of screening. Medical and sexual history, a pelvic exam, cervicovaginal lavage sample collection, blood collection, vaginal pH testing, STI testing, and adverse effect reporting will occur at all visits. All participants will be asked to complete a diary throughout the study; this diary will be reviewed at all study visits. A Pap smear will be obtained at screening if documentation of a negative Pap smear result within the last year is not available.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
30
1 gm/100 ml of 1% tenofovir gel vaginally daily
1 gm/100 ml of placebo gel vaginally daily
Albert Einstein College of Medicine - East Campus GCRC (Herold) Non-Network CRS
The Bronx, New York, United States
Changes in cytokines, chemokines, and other mediators of innate immunity through examination of cervicovaginal secretions
Time frame: At Days 3, 7, 14, and 21
Changes in antimicrobial activity of cervicovaginal secretions
Time frame: At Day 14
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