Safety of Acidform Lubricant in HIV-Uninfected Women
Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease pathogens. 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 compare the safety of daily applications of Acidform lubricant and HEC gel in healthy women at low risk for HIV infection and assess the effect of a microbicide candidate on the natural immunity women have to STI pathogens.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety of Acidform Lubricant (Amphora) in Women at Low Risk for HIV-1 Infection|
- Measured endogenous antimicrobial activity [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Measured levels of mediators of host defense, including defensins, cytokines, and chemokines in CVL [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Extent and duration of buffering measured by vaginal pH [ Time Frame: Prior to and 2 hours after first application ] [ Designated as safety issue: No ]
- Changes in epithelial integrity after Acidform and HEC application [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Changes in vaginal flora following Acidform and HEC application [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Antiviral activity in CVL following Acidform and HEC application [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
Participants will apply Acidform lubricant twice daily for 14 consecutive days between menses
Drug: Acidform Lubricant
5 g application of acid buffered gel (pH = 3.5)
Other Name: Amphora
Placebo Comparator: 2
Participants will apply HEC gel twice daily for 14 consecutive days between menses
Drug: HEC gel
5 g application of hydroxyethylcellulose gel
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 Acidform lubricant and HEC gel in two groups of healthy women at low risk for HIV infection.
The duration of this study for each participant is 3 weeks. Study participants will be randomly assigned to one of two study groups. Group 1 participants will apply Acidform lubricant twice daily for 14 consecutive days between menses. Group 2 participants will apply HEC gel for 14 consecutive days between menses.
After screening and study entry, study visits will occur on Days 7, 14, and 21. Study entry will occur 2 to 6 days following the menses and within 45 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. Cytobrush collection, vaginal swab, and cervical biopsy will occur at selected 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850837
|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|