NCT00389311

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Apr 2007

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 1, 2015

Status Verified

January 1, 2009

Enrollment Period

10 months

First QC Date

October 17, 2006

Last Update Submit

March 30, 2015

Conditions

HIV Infections

Keywords

MicrobicideSafetyHIV preventionHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

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

    0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours and 12-24 hours after introduction of the treatment assignment

Study Arms (3)

Nonoxynol-9

ACTIVE COMPARATOR

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

Drug: Nonoxynol-9

Normosol-R

OTHER

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

Drug: Normosol-R

Normosol with simulation, endoscopy and biopsy

EXPERIMENTAL

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

Drug: Normosol-RProcedure: Gastrointestinal instrumentation

Interventions

Normosol-RDRUG
Normosol with simulation, endoscopy and biopsyNormosol-R
Nonoxynol-9DRUG
Nonoxynol-9
Gastrointestinal instrumentationPROCEDURE
Normosol with simulation, endoscopy and biopsy

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • 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.

    PMID: 23325915RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Plasmalyte ANonoxynol

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsEthylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Edward Fuchs, PA-C, MBA

    The Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Medicine

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 18, 2006

Study Start

April 1, 2007

Primary Completion

February 1, 2008

Study Completion

June 1, 2009

Last Updated

April 1, 2015

Record last verified: 2009-01

Locations

US(1)