Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Effect of Repeated Applications of Tenofovir Gel on Mucosal Mediators of Immunity and Intrinsic Antimicrobial Activity of Cervicovaginal Secretions in Women at Low Risk for HIV-1 Infection|
- Changes in cytokines, chemokines, and other mediators of innate immunity through examination of cervicovaginal secretions [ Time Frame: At Days 3, 7, 14, and 21 ] [ Designated as safety issue: Yes ]
- Changes in antimicrobial activity of cervicovaginal secretions [ Time Frame: At Day 14 ] [ Designated as safety issue: Yes ]
|Study Completion Date:||April 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Application of 1% tenofovir gel for 14 consecutive days between menses
Drug: Tenofovir gel
1 gm/100 ml of 1% tenofovir gel vaginally daily
Placebo Comparator: 2
Application of 1% tenofovir placebo gel for 14 consecutive days between menses
Drug: Tenofovir gel placebo
1 gm/100 ml of placebo gel vaginally daily
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.
|United States, New York|
|Albert Einstein College of Medicine - East Campus GCRC (Herold) Non-Network CRS|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Marla Keller, MD||Albert Einstein College of Medicine of Yeshiva University|
|Principal Investigator:||Betsy Herold, MD||Albert Einstein College of Medicine of Yeshiva University|