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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00075062 |
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 | Intervention |
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HIV Infections HIV Seronegativity |
Procedure: Flexible Sigmoidoscopy Procedure: Rectal Biopsy |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Characteristics of Baseline Mucosal Indices of Injury and Inflammation in Men For Use in Rectal Microbicide Trials |
Estimated 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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:
United States, California | |
David Geffen School of Medicine at UCLA | |
Los Angeles, California, United States, 90095 |
Study Chair: | Ian McGowan, MD, PhD | University of California, Los Angeles |
Study Chair: | Peter Anton, MD | University of California, Los Angeles |
Study ID Numbers: | HPTN 056 |
Study First Received: | December 31, 2003 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00075062 |
Health Authority: | United States: Federal Government |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes Inflammation |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |