Status:
COMPLETED
Safety of Acidform Lubricant in HIV-Uninfected Women
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief Summary
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 t...
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 H...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00850837
Start Date
February 1 2009
Last Update
December 3 2013
Active Locations (1)
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1
Albert Einstein College of Medicine - East Campus GCRC (Herold) Non-Network CRS
The Bronx, New York, United States, 10461