Home | | | Search | | | Browse | | | Resources | | | Help | | | What's New | | | About |
---|
A Study of Male Rectal Samples in Preparation for Future Rectal Microbicide Trials
This study is currently recruiting patients.
Sponsored by: | National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
Purpose
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.
Condition | Treatment or Intervention |
---|---|
HIV Infections HIV Seronegativity |
Procedure: Flexible Sigmoidoscopy Procedure: Rectal Biopsy |
MedlinePlus related topics: AIDS
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study
Official Title: Characteristics of Baseline Mucosal Indices of Injury and Inflammation in Men For Use in Rectal Microbicide Trials
Expected Total Enrollment: 16
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.
Eligibility
Ages Eligible for Study: 18 Years - 50 Years, Genders Eligible for Study: Male
Accepts Healthy Volunteers
Criteria
Inclusion Criteria for All Participants:
Inclusion Criteria for Men Practicing Anal-Receptive Sex (Groups 1, 3 and 4):
Inclusion Criteria for Men Not Practicing Anal-Receptive Sex (Group 2)
Inclusion Criteria for HIV Infected Men (Groups 3 and 4):
Exclusion Criteria:
Location and Contact Information
More Information
Click here for more information about microbicides
Haga clic aquí para ver información sobre este ensayo clínico en español.
Publications
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
Copyright, Privacy, Accessibility, Freedom of Information Act |