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A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00389311
Recruitment Status : Completed
First Posted : October 18, 2006
Last Update Posted : April 1, 2015
Information provided by (Responsible Party):
Craig W. Hendrix, Johns Hopkins University

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Normosol-R Drug: Nonoxynol-9 Procedure: Gastrointestinal instrumentation Early Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
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
Study Start Date : April 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Nonoxynol-9
Gynol-II, 2% N-9, 5 mL
Drug: Nonoxynol-9
Normosol-R, 5 mL, single administration, negative control
Drug: Normosol-R
Experimental: Normosol with simulation, endoscopy and biopsy
Normosol-R, 5 mL following simulation, endoscopy and biopsy
Drug: Normosol-R
Procedure: Gastrointestinal instrumentation

Primary Outcome Measures :
  1. Intra-subject comparison of urine and plasma concentrations of 99mTc-DTPA [ Time Frame: 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours and 12-24 hours after introduction of the treatment assignment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Greater than or equal to 21 years of age
  • Prior history of receptive anal intercourse (RAI)
  • Subjects must have a history of using commercially-available personal lubricants for RAI.
  • Ability to provide signed informed consent.
  • Willingness to abstain from lubricant use and anal receptive intercourse for 48 hours prior to and 48 hours after Phases A and B.
  • Willingness to use a single dose of rectally-applied N-9.

Exclusion Criteria:

  • Mental handicap or impaired cognitive performance status as judged by the investigator.
  • Coagulation abnormality which would put the subject at risk for bleeding as judged by the Principal Investigator.
  • History of anorectal surgery within the last month or the presence of any anorectal disease or condition that in the judgment of the investigator could affect permeability of the rectal mucosa.
  • Presence of any painful anorectal conditions or anorectal lesions that would be tender to manipulation.
  • History of occupational radiation exposure.
  • History of acute or chronic diarrhea defined as three or more loose stools per day.
  • History of any allergic response to rectal lubricants.
  • History of sleep apnea, or airway problems with previous sedation procedures.
  • History of significant adverse reaction to sedation medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00389311

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United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Edward Fuchs, PA-C, MBA The Johns Hopkins University
Publications of Results:
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Responsible Party: Craig W. Hendrix, Professor, Department of Medicine, Johns Hopkins University Identifier: NCT00389311    
Other Study ID Numbers: CDC 200-2001-08015-02
First Posted: October 18, 2006    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: January 2009
Keywords provided by Craig W. Hendrix, Johns Hopkins University:
HIV prevention
HIV Seronegativity
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Spermatocidal Agents
Antispermatogenic Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Male