Safety and Acceptability Study of the UC-781 Microbicide Gel Applied Rectally
|First Submitted Date ICMJE||December 6, 2006|
|First Posted Date ICMJE||December 7, 2006|
|Last Update Posted Date||May 4, 2009|
|Start Date ICMJE||December 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00408538 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Safety and Acceptability Study of the UC-781 Microbicide Gel Applied Rectally|
|Official Title ICMJE||A Phase 1 Randomized, Blinded, Placebo-Controlled Safety and Acceptability Study of the UC-781 Vaginal Microbicide Gel Formulation Applied Rectally in HIV-1 Seronegative Adults|
This study is the first to try this product in the rectum of humans. This study is only to find out if the gel is safe for use in the rectum, not to see if the gel works. Information gathered from this study will help investigators decide whether this gel is safe enough to move onto the next phase of studies.
Information gathered from this study will also help investigators determine what participants did and did not like about the product and what types of products people might want to use in the future. Currently condoms and abstinence are the only methods proven to prevent the spread of HIV sexually.
The purpose of this study is to obtain preliminary data on the safety and acceptability of UC-781 vaginal microbicide gel (0.1% and 0.25%) versus placebo when rectally administered in HIV-1 seronegative adults.
Participants will enter a screening period, which includes Visit 1 and if necessary a medication washout period.
Subjects who are deemed eligible after this screening period will return for a baseline evaluation (Visit 2), including clinical evaluation and mucosal specimen collection, as well as the Baseline Behavioral Questionnaire (BBQ). The BBQ will be administered by Computer Assisted Self-Interview (CASI). Subjects may complete the web-based CASI in the privacy of their own home. If a subject does not have access to the Internet, prefers to complete the BBQ at the study site, or requires assistance in using the CASI, he or she will be accommodated at the study site.
After completing Visits 1 and 2, eligible subjects will be randomized to one of three groups: 0.1% UC-781 gel, 0.25% UC-781 gel, or a placebo gel (12 per group). A subset of 9 subjects (3 from each group) will also participate in a pK sub-study, which will include 6 timepoints (Visit 3- pre, 0.25 hr, 2 hr, 4 hr, Visit 3A- 24 hr, and Visit 5- 1 day post-QD dose). During randomization, study staff will be notified if the participant is randomized to the pK substudy.
This study will involve 2 stages of treatment. Each treatment stage is independent of the other. This study aims to examine the effects of 2 different dosing regimens, NOT cumulative safety over the both stages.
Once randomized, subjects will return to the clinic (Visit 3), where a single dose of the study gel (Treatment Stage 1) will be administered followed by clinical evaluation, including flexible sigmoidoscopy, and sample collection.
Subjects will return to the clinic for Treatment Stage 2 Clearance (Visit 4), in the week prior to beginning Treatment Stage 2. If given clearance, the subject may begin Treatment Stage 2.
In Treatment Stage 2, subjects will begin to self-administer once daily outpatient doses of the study gel for 7 days. After completion of Stage 2 the subject will complete a Product Acceptability Questionnaire (PAQ) by CASI and return to clinic for evaluation and specimen collection (Visit 5).
After completion of Visit 5, subjects will be contacted by an interviewer to complete an in-depth phone interview regarding product acceptability.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Condition ICMJE||HIV Infections|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||36|
|Completion Date||April 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Men who meet the following 10 criteria and women who meet the following 12 criteria are eligible for inclusion in the study:
Individuals who meet any of the following criteria at screening will be excluded from the study:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00408538|
|Other Study ID Numbers ICMJE||U19-AI060614:P4 Aim 1
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of California, Los Angeles|
|Investigators ICMJE||Not Provided|
|PRS Account||University of California, Los Angeles|
|Verification Date||May 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP