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A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides

Primary Purpose

HIV Infections

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Normosol-R

Nonoxynol-9

Gastrointestinal instrumentation

About this trial

This is an interventional diagnostic trial for HIV Infections focused on measuring Microbicide, Safety, HIV prevention, HIV Seronegativity

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

The Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Experimental

Arm Label

Nonoxynol-9

Normosol-R

Normosol with simulation, endoscopy and biopsy

Arm Description

Gynol-II, 2% N-9, 5 mL

Normosol-R, 5 mL, single administration, negative control

Normosol-R, 5 mL following simulation, endoscopy and biopsy

Outcomes

Primary Outcome Measures

Intra-subject comparison of urine and plasma concentrations of 99mTc-DTPA

Secondary Outcome Measures

Full Information

NCT ID

NCT00389311

First Posted

October 17, 2006

Last Updated

March 30, 2015

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT00389311

Brief Title

A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides

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 Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johns Hopkins University

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Microbicide, Safety, HIV prevention, HIV Seronegativity

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nonoxynol-9

Arm Type

Active Comparator

Arm Description

Gynol-II, 2% N-9, 5 mL

Arm Title

Normosol-R

Arm Type

Other

Arm Description

Normosol-R, 5 mL, single administration, negative control

Arm Title

Normosol with simulation, endoscopy and biopsy

Arm Type

Experimental

Arm Description

Normosol-R, 5 mL following simulation, endoscopy and biopsy

Intervention Type

Drug

Intervention Name(s)

Normosol-R

Intervention Type

Drug

Intervention Name(s)

Nonoxynol-9

Intervention Type

Procedure

Intervention Name(s)

Gastrointestinal instrumentation

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward Fuchs, PA-C, MBA

Organizational Affiliation

The Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23325915

Citation

Fuchs EJ, Grohskopf LA, Lee LA, Bakshi RP, Hendrix CW. Quantitative assessment of altered rectal mucosal permeability due to rectally applied nonoxynol-9, biopsy, and simulated intercourse. J Infect Dis. 2013 May 1;207(9):1389-96. doi: 10.1093/infdis/jit030. Epub 2013 Jan 16.

Results Reference

result

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A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides

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