- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00850837
Safety of Acidform Lubricant in HIV-Uninfected Women
Safety of Acidform Lubricant (Amphora) in Women at Low Risk for HIV-1 Infection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Albert Einstein College of Medicine - East Campus GCRC (Herold) Non-Network CRS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Normal menstrual history with regular cycles and with a minimum of 21 days between menses
- Low risk for HIV/STI infection. More information on this criterion can be found in the protocol.
- Agree to abstain from vaginal and anal intercourse and to not use vaginal products within 48 hours prior to study entry and for the duration of the study
Exclusion Criteria:
- HIV-infected
- Menopausal
- Currently using hormonal contraception or have used hormonal contraception within 2 months of study entry
- Menstruating at screening or enrollment visits
- Urinary tract infection at screening
- Positive chlamydia, gonorrhea, or trichomonas result at screening
- Abnormal Pap smear
- Clinically detectable genital abnormality. More information on this criterion can be found in the protocol.
- Currently participating in a research study of other vaginal products
- History of intermenstrual bleeding within 3 months prior to study entry
- Previous gynecologic surgery or have received treatment for syphilis, genital herpes, chlamydia, gonorrhea, trichomonas, or genital warts within 6 months prior to study entry
- Received treatment for Candida, bacterial vaginosis, or urinary tract infection within 1 month prior to study entry
- Have douched or used vaginal products, including lubricants, feminine hygiene products, vaginal drying agents, and sex toys within 48 hours prior to study entry
- Vaginal or anal intercourse during the 48 hours prior to study entry
- Oral antibiotics within 7 days of study entry
- Pregnant, less than 6 months postpartum, or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Participants will apply Acidform lubricant twice daily for 14 consecutive days between menses
|
5 g application of acid buffered gel (pH = 3.5)
Other Names:
|
Placebo Comparator: 2
Participants will apply HEC gel twice daily for 14 consecutive days between menses
|
5 g application of hydroxyethylcellulose gel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measured endogenous antimicrobial activity
Time Frame: Throughout study
|
Throughout study
|
Measured levels of mediators of host defense, including defensins, cytokines, and chemokines in CVL
Time Frame: Throughout study
|
Throughout study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Extent and duration of buffering measured by vaginal pH
Time Frame: Prior to and 2 hours after first application
|
Prior to and 2 hours after first application
|
Changes in epithelial integrity after Acidform and HEC application
Time Frame: Throughout study
|
Throughout study
|
Changes in vaginal flora following Acidform and HEC application
Time Frame: Throughout study
|
Throughout study
|
Antiviral activity in CVL following Acidform and HEC application
Time Frame: Throughout study
|
Throughout study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marla Keller, MD, Albert Einstein College of Medicine
Publications and helpful links
General Publications
- Anderson DJ, Williams DL, Ballagh SA, Barnhart K, Creinin MD, Newman DR, Bowman FP, Politch JA, Duerr AC, Jamieson DJ. Safety analysis of the diaphragm in combination with lubricant or acidifying microbicide gels: effects on markers of inflammation and innate immunity in cervicovaginal fluid. Am J Reprod Immunol. 2009 Feb;61(2):121-9. doi: 10.1111/j.1600-0897.2008.00670.x.
- Behets FM, Turner AN, Van Damme K, Rabenja NL, Ravelomanana N, Swezey TA, Bell AJ, Newman DR, Williams DL, Jamieson DJ; Mad STI Prevention Group. Vaginal microbicide and diaphragm use for sexually transmitted infection prevention: a randomized acceptability and feasibility study among high-risk women in Madagascar. Sex Transm Dis. 2008 Sep;35(9):818-26. doi: 10.1097/OLQ.0b013e318175d8ab.
- Williams DL, Newman DR, Ballagh SA, Creinin MD, Barnhart K, Weiner DH, Bell AJ, Jamieson DJ. Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm. Sex Transm Dis. 2007 Dec;34(12):977-84. doi: 10.1097/olq.0b013e31813347e9.
- Keller MJ, Carpenter CA, Lo Y, Einstein MH, Liu C, Fredricks DN, Herold BC. Phase I randomized safety study of twice daily dosing of acidform vaginal gel: candidate antimicrobial contraceptive. PLoS One. 2012;7(10):e46901. doi: 10.1371/journal.pone.0046901. Epub 2012 Oct 8.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Keller 069551 AF020
- U01AI069551 (U.S. NIH Grant/Contract)
- 10740 (Registry Identifier: DAIDS ES)
- AF 020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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