Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Johns Hopkins University |
---|---|
Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00389311 |
The purpose of this study is to determine if detectable changes in permeability of the lining of the colon are caused by either application of HIV microbicide gels or medical procedures, such as flexible sigmoidoscopy.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Normosol-R Drug: Nonoxynol-9 Procedure: Gastrointestinal instrumentation |
Phase 0 |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety Study |
Official Title: | A Pilot Protocol to Determine the Effects of Chemical and Mechanical Stress on Rectal Permeability as a Surrogate for Toxicity Evaluation of Rectally Applied Microbicides |
Estimated Enrollment: | 10 |
Study Start Date: | April 2007 |
It is not currently known if procedures used to observe the lining of the distal colon, such as endoscopy with or without pinch biopsy, may cause mucosal trauma and thus alter colonic permeability. Additionally, the application of topical HIV microbicides (to prevent HIV transmission) and shearing forces associated with rectal intercourse might also adversely affect the epithelial layer, and thus alter colonic permeability. In order to appropriately interpret testing of the effects of topical HIV microbicides on the mucosal lining of the distal colon, it is essential to understand whether these procedures themselves, adversely affect the epithelial layer. If changes in permeability can be detected, this method may be developed to help determine microbicide distribution/toxicity in early phase studies, thus improving the selection of candidate microbicides for study in larger scale clinical trials.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
The Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Edward Fuchs, PA-C, MBA | The Johns Hopkins University |
Study ID Numbers: | CDC 200-2001-08015-02 |
Study First Received: | October 17, 2006 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00389311 |
Health Authority: | United States: Institutional Review Board |
Microbicide Safety HIV prevention HIV Seronegativity |
Nonoxynol Virus Diseases Sexually Transmitted Diseases, Viral Octoxynol HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Stress Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Contraceptive Agents Physiological Effects of Drugs Contraceptive Agents, Female Reproductive Control Agents |
Contraceptive Agents, Male Infection Pharmacologic Actions Therapeutic Uses Lentivirus Infections Antispermatogenic Agents Spermatocidal Agents |