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Sponsors and Collaborators: |
CONRAD Emory University Centers for Disease Control and Prevention |
Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00132444 |
This study will help determine whether the agent UC-781, formulated as a gel, is safe when applied to the vagina twice daily for 14 days. It will also assess whether women find the gel acceptable to use.
Condition | Intervention | Phase |
HIV Infections |
Drug: topical vaginal application of UC-781 gel |
Phase I |
MedlinePlus related topics: | AIDS |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Phase I Study of the Safety and Acceptability of UC-781 Topical Vaginal Microbicide in Heterosexual Women and Their Male Partners |
Estimated Enrollment: | 90 |
Study Start Date: | October 2005 |
Arms | Assigned Interventions |
1: Active Comparator
0.25% gel
|
Drug: topical vaginal application of UC-781 gel
UC-781 gel (arms 1 and 2) or placebo (arm 3) applied vaginally twice daily for 14 days
|
2: Active Comparator
0.1% gel
|
Drug: topical vaginal application of UC-781 gel
UC-781 gel (arms 1 and 2) or placebo (arm 3) applied vaginally twice daily for 14 days
|
3: Placebo Comparator |
Drug: topical vaginal application of UC-781 gel
UC-781 gel (arms 1 and 2) or placebo (arm 3) applied vaginally twice daily for 14 days
|
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Show Detailed Description |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
For All Females:
Agree to abstain from the following activities from at least 48 hours prior to enrollment through the Day 14 visit:
Additional Inclusion Criteria for Stage 1:
Additional Inclusion Criteria for Stage 2:
Inclusion Criteria for Male Partners:
Exclusion Criteria:
Exclusion Criteria for All Females:
In the three months prior to enrollment have had any of the following:
In the six months prior to enrollment have had any of the following:
Additional Exclusion Criteria for Stage 1:
Additional Exclusion Criteria for Stage 2:
United States, Georgia | |||||
Hope Clinic of Emory University | Recruiting | ||||
Decatur, Georgia, United States, 30030 | |||||
Contact: Frances H Priddy, MD, MPH 404-377-3719 ext 14 fpriddy@emory.edu | |||||
Contact: Zabrina Furlow 404-377-3719 ext 18 zfurlow@emory.edu | |||||
Principal Investigator: Frances H Priddy, MD, MPH |
CONRAD |
Emory University |
Centers for Disease Control and Prevention |
Principal Investigator: | Kimberly Workowski, MD | Emory University |
Study ID Numbers: | CDC-NCHSTP-4413 |
First Received: | July 11, 2005 |
Last Updated: | September 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00132444 |
Health Authority: | United States: Food and Drug Administration |
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