Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women
|ClinicalTrials.gov Identifier: NCT00594373|
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : September 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Tenofovir gel Drug: Tenofovir gel placebo||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||April 2010|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594373
|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, Inc.|
|Principal Investigator:||Betsy Herold, MD||Albert Einstein College of Medicine, Inc.|