Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075062
Status:
COMPLETED
Last Update Posted:
2008-08-21
First Post:
2003-12-31
Brief Title:
A Study of Male Rectal Samples in Preparation for Future Rectal Microbicide Trials
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Characteristics of Baseline Mucosal Indices of Injury and Inflammation in Men For Use in Rectal Microbicide Trials
Status:
COMPLETED
Status Verified Date:
2006-05
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:
Microbicides are drugs that destroy microbes such as viruses and bacteria Rectal microbicides may be able to prevent transmission of HIV during anal intercourse The purpose of this study is to obtain rectal samples from men to learn information that may be valuable in future clinical trials of rectal microbicides
Detailed Description:
Rectal microbicides to prevent HIV transmission are currently being developed in the hope that someday they will be widely used to prevent sexually transmitted HIV This study will examine variables in male rectal tissue this information may be useful for future rectal microbicide safety and efficacy studies The study will evaluate the differences in rectal tissue from HIV infected or uninfected males who either engage in anal-receptive sex men who sleep with men or MSM or do not have anal-receptive sex
The study will last approximately 7 months with 6 weeks of follow-up There are four groups in this study Groups 1 and 2 will enroll HIV uninfected men Groups 3 and 4 will enroll HIV infected men Groups 1 3 and 4 will comprise MSM who engage in anal-receptive sex Group 2 will comprise men who do not Patients will provide medical and medication history undergo a complete physical exam and receive HIV counseling at screening An anoscopy examination of the anus anal canal and lower rectum and blood draw will be conducted at screening study entry and Weeks 2 and 4 Rectal secretions will be collected and a sigmoidoscopy an internal examination of the rectum distal sigmoid colon and large bowel using a small camera will be performed at study entry and Weeks 2 and 4
The study will last approximately 7 months with 6 weeks of follow-up There are four groups in this study Groups 1 and 2 will enroll HIV uninfected men Groups 3 and 4 will enroll HIV infected men Groups 1 3 and 4 will comprise MSM who engage in anal-receptive sex Group 2 will comprise men who do not Patients will provide medical and medication history undergo a complete physical exam and receive HIV counseling at screening An anoscopy examination of the anus anal canal and lower rectum and blood draw will be conducted at screening study entry and Weeks 2 and 4 Rectal secretions will be collected and a sigmoidoscopy an internal examination of the rectum distal sigmoid colon and large bowel using a small camera will be performed at study entry and Weeks 2 and 4
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