HIV InfectionsEarly Phase 1NCT00389311
A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides
A Early Phase 1 study testing Normosol-R, Nonoxynol-9 and Gastrointestinal instrumentation in people with HIV Infections, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Normosol-R, Nonoxynol-9 and Gastrointestinal instrumentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jun 2009
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this 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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Normosol-R, Nonoxynol-9, Gastrointestinal instrumentation
- Keywords
- Microbicide, Safety, HIV prevention, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normosol-RDrug
Nonoxynol-9Drug
Gastrointestinal instrumentationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Nonoxynol-9 | Active comparator | Gynol-II, 2% N-9, 5 mL Receives: Drug: Nonoxynol-9 |
| Normosol-R | Other | Normosol-R, 5 mL, single administration, negative control Receives: Drug: Normosol-R |
| Normosol with simulation, endoscopy and biopsy | Experimental | Normosol-R, 5 mL following simulation, endoscopy and biopsy Receives: Drug: Normosol-R; Procedure: Gastrointestinal instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-subject comparison of urine and plasma concentrations of 99mTc-DTPA
Measured: 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours and 12-24 hours after introduction of the treatment assignment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2006 (estimated)
- Study startApr 2007
- Primary completionFeb 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig W. Hendrix, Johns Hopkins University
- Investigators
- Edward Fuchs, PA-C, MBA, Principal investigator, The Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389311
- Sponsor's protocol ID
- CDC 200-2001-08015-02
- Status last verified
- Jan 2009
- First submitted
- 17 Oct 2006
- Last updated
- 1 Apr 2015
- Results posted
- No
Publications
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.
PubMed 23325915
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00389311
- Acronym / sponsor ID
- CDC 200-2001-08015-02
- Conditions
- HIV Infections
- Keywords
- Microbicide, Safety, HIV prevention, HIV Seronegativity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nonoxynol-9 | Active comparator | Drug: Nonoxynol-9Gynol-II, 2% N-9, 5 mL |
| Normosol-R | Other | Drug: Normosol-RNormosol-R, 5 mL, single administration, negative control |
| Normosol with simulation, endoscopy and biopsy | Experimental | Drug: Normosol-R, Procedure: Gastrointestinal instrumentationNormosol-R, 5 mL following simulation, endoscopy and biopsy |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normosol-R | Drug | Normosol with simulation, endoscopy and biopsy, Normosol-R |
| Nonoxynol-9 | Drug | Nonoxynol-9 |
| Gastrointestinal instrumentation | Procedure or surgery | Normosol with simulation, endoscopy and biopsy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Results publication: PubMed 23325915Fuchs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Fuchs, PA-C, MBA principal investigator
The Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Normosol-R, Nonoxynol-9 and Gastrointestinal instrumentation in people with HIV Infections, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00389311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.