Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408538
Status:
COMPLETED
Last Update Posted:
2009-05-04
First Post:
2006-12-06
Brief Title:
Safety and Acceptability Study of the UC-781 Microbicide Gel Applied Rectally
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
The purpose of this study is to obtain preliminary data on the safety and acceptability of UC-781 vaginal microbicide gel 01 and 025 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 01 UC-781 gel 025 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 025 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
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 01 UC-781 gel 025 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 025 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-04-043 | None | None | None |