A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides

This study has been completed.
Information provided by (Responsible Party):
Craig W. Hendrix, Johns Hopkins University
ClinicalTrials.gov Identifier:
First received: October 17, 2006
Last updated: March 30, 2015
Last verified: January 2009
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: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: April 2007
Study Completion Date: June 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   21 Years and older
Genders 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00389311

United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Edward Fuchs, PA-C, MBA The Johns Hopkins University
  More Information

Responsible Party: Craig W. Hendrix, Professor, Department of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00389311     History of Changes
Other Study ID Numbers: CDC 200-2001-08015-02 
Study First Received: October 17, 2006
Last Updated: March 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
HIV prevention
HIV Seronegativity

Additional relevant MeSH terms:
Anti-Infective Agents
Plasma-lyte 148
Antispermatogenic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Ophthalmic Solutions
Pharmaceutical Solutions
Physiological Effects of Drugs
Reproductive Control Agents
Spermatocidal Agents

ClinicalTrials.gov processed this record on May 26, 2016