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Tracking Information | |||||
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First Received Date † | February 24, 2009 | ||||
Last Updated Date | February 24, 2009 | ||||
Start Date † | |||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Safety of Acidform Lubricant in HIV-Uninfected Women | ||||
Official Title † | Safety of Acidform Lubricant (Amphora) in Women at Low Risk for HIV-1 Infection | ||||
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 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. |
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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 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. 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. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Parallel Assignment, Safety Study | ||||
Condition † | HIV Infections | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Not yet recruiting | ||||
Enrollment † | 36 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years to 50 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00850837 | ||||
Responsible Party | Rona Siskind, DAIDS | ||||
Secondary IDs †† | U01 AI069551 | ||||
Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
Verification Date | January 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |