HIV InfectionsNCT00696618
Enema Use and Acceptability in HIV Negative Men Who Have Sex With Men
A study testing Fleet Enema, tap water enema and Normosol-R enema in people with HIV Infections, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study is looking at 3 different types of enemas used before receptive anal intercourse in men who have sex with men (MSM). We are investigating whether the enemas cause any damage to the lining of the colon, how far up the colon the enemas travel after they are given, and how much study participants like using… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Fleet Enema, tap water enema and Normosol-R enema
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- ≥ Age of 18
- HIV-1 status antibody negative as documented at screening
- A history of RAI at least twice per month in the prior 3 months*
- Required to assure that subjects are likely to complete each stage of enema test article use in a reasonable amount of time.
- History of enema use prior to RAI at least some of the time
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- Willing to use each study product prior to RAI on 3 separate occasions.
- Willing to refrain from RAI for 48 hours before and after inpatient periods.
- Willing to use condoms for the duration of the study
- Availability to return for all study visits, barring unforeseen circumstances
- Understands and agrees to local Sexually Transmitted Infection (STI) reporting requirements
- Able and willing to communicate in English
- Able and willing to provide written informed consent to take part in the study
- Able and willing to provide adequate information for locator purposes
Who cannot join
- Female
- HIV positive at baseline
- History of inflammatory bowel disease
- Active inflammatory condition of the GI tract at baseline
- Active rectal infection at Visit 2 (Infections identified during the screening period must be treated prior to Visit 2)
- Presence of any painful anorectal conditions that would be tender to manipulation. (Participants with hemorrhoids and/or anal warts that are not painful may participate.)
Show all 14Show fewer
- History of prosthetic cardiac valves, including bioprosthetic and homograft valves, previous bacterial endocarditis, surgically constructed systemic pulmonary shunts or conduits, and complex cyanotic congenital heart disease such as single ventricle states, transposition of the great arteries, tetralogy of Fallot or similar conditions that put the subject at high risk for bacteremia during endoscopy, hence requiring antibiotic prophylaxis.
- Unwillingness to refrain from chronic use of aspirin and NSAIDs.
- Use of warfarin or heparin
- Use of systemic immunomodulatory medications within 72 hours of Visit 2 baseline
- Use of rectally administered medications, including over-the-counter enemas, within 72 hours of Visit 2 baseline
- Use of product containing nonoxynol-9 rectally within 72 hours of Visit 2
- Use of any investigational products within 72 hours of Visit 2 baseline
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral disease, or coagulopathies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blinded, Comparative Study of the Mucosal Toxicity, Colorectal Distribution, and Participant Acceptability of Three Different Preparatory Enemas (Hypo-, Iso-, and Hyper-osmolar)
This study is looking at 3 different types of enemas used before receptive anal intercourse in men who have sex with men (MSM). We are investigating whether the enemas cause any damage to the lining of the colon, how far up the colon the enemas travel after they are given, and how much study participants like using each of the enemas.
Read the detailed description
Research participants who are deemed eligible after screening will return for a baseline evaluation. The baseline visit includes clinical evaluation and colon tissue collection, as well as a Baseline Behavioral Questionnaire (BBQ). The BBQ will be administered by Computer Assisted Self-Interview (CASI). Participants may complete the web-based CASI in the privacy of their own home.
Following the baseline visit, participants will be randomized into one of three groups. Each group will receive enemas of varying osmolality (molecule concentrations) in a different sequence according to study stage. During each stage of enema test product use participants will receive a single inpatient dose followed by three outpatient doses to be used in the context of Receptive Anal Intercourse (RAI).
This study will involve 3 stages of enema test product use. Each stage is identical, with the exception of the enema osmolality. Each stage includes an inpatient period and an outpatient period. The time period between stages 1, 2, and 3 will be approximately 2-6 weeks to allow for a recovery period, opportunities for product use, and appointment availability. The participant's inpatient portion of the study will take place as scheduling permits after the at-home enema use is complete.
During each stage, the participant is admitted to the inpatient unit for <48 hours, placed on a clear liquid diet, and has an interval medical history and directed physical exam. The following day the 125ml study enema is radiolabeled and administered to the participant. Over an approximately 25 hour time period, the participant will undergo pharmacokinetic studies involving blood drawing, colon tissue sample collection by flexible sigmoidoscopy, and imaging by Single Photon Emission Computed Tomography/ paired with x-ray Computed Tomography (SPECT/CT). The participant will then be discharged home with 3 doses of study enema. Participants will be instructed to allow for an approximately 72 hour recovery period (to ensure healing of the colon tissue biopsy sites) prior to initiating use of the study product on an outpatient basis, if applicable. Subjects will be encouraged to use the study product on 3 separate occasions in the context of RAI. As with standard HIV counseling, participants will be encouraged to use condoms. After each outpatient use the subject will complete a Brief Acceptability Questionnaire (BAQ). Then at the end of each stage of enema test article use, the subject will complete a Product Acceptability Questionnaire (PAQ).
Study Exit Interview At completion of all 3 stages the participant will complete an Overall Product Preference Questionnaire (OPPQ) administered by CASI followed by and in-depth interview.
- Conditions
- HIV Infections
- Being tested
- Fleet Enema, tap water enema, Normosol-R enema
- Keywords
- HIV prevention, MSM, Enema, 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.
Fleet EnemaDrug
Also called hyperosmolar enema
hyper-osmolar preparation
tap water enemaDrug
Also called hypo-osmolar enema
hypo-osmolar preparation
Normosol-R enemaDrug
Also called iso-osmolar enema
iso-osmolar preparation
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home(Stage 2), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3) Receives: Drug: Fleet Enema; Drug: tap water enema; Drug: Normosol-R enema |
| B | Experimental | Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3) Receives: Drug: Fleet Enema; Drug: tap water enema; Drug: Normosol-R enema |
| C | Experimental | Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Normosol-R enema(iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3) Receives: Drug: Fleet Enema; Drug: tap water enema; Drug: Normosol-R enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal Toxicity Using Histopathology
Endoscopy will be performed to obtain biopsy specimens at baseline and following each inpatient enema exposure. Samples will be obtained at each flexible sigmoidoscopy and set aside for batch sectioning and H\&E staining. Slides will be reviewed and scored by a qualified pathologist blinded to treatment assignment using a qualitative scoring system. This scoring system uses semi-quantitative scoring that focuses on acute toxicity to epithelial cell layer similar to that seen in animal studies. This is a categorical grading scale, where 0 = Epithelial surface intact;1 = <1/3 of surface denuded; 2 = 1/3 - 2/3rds of surface denuded;3 = More than 2/3rds of surface denuded.
Six separate biopsies for each subject and each treatment intervention were analyzed in a multi-level analysis. In comparison with the baseline condition (no intervention), the odds and 95% confidence interval (CI) of having a higher epithelial denudation score were calculated for each intervention.
Measured: One hour following enema exposure
Secondary outcomes (2)
Radiolabel Area Under the Curve (AUC 0-24 hr)
Percent of radiolabel dose administered was determined by plasma sampling at standardized intervals over 24 hours. AUC was then calculated using the trapezoidal rule and reported as x10 log 7 microcurie-hours/mL
Measured: 24 hours following each intervention
D(Average) at Two Hours
Mean proximal residence distance of radio-signal from anus as measured on SPECT/CT
Measured: two hours following dosing of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startJul 2007
- Primary completionJul 2009
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Craig Hendrix, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696618
- Sponsor's protocol ID
- NA_00010972
- Status last verified
- Mar 2017
- First submitted
- 4 Jun 2008
- Last updated
- 28 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Comparative Study of the Mucosal Toxicity, Colorectal Distribution, and Participant Acceptability of Three Different Preparatory Enemas (Hypo-, Iso-, and Hyper-osmolar)
- ClinicalTrials.gov ID
- NCT00696618
- Acronym / sponsor ID
- NA_00010972
- Conditions
- HIV Infections
- Keywords
- HIV prevention, MSM, Enema, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Jul 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Jun 2008 (estimated)
- Results
- Posted 28 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is looking at 3 different types of enemas used before receptive anal intercourse in men who have sex with men (MSM). We are investigating whether the enemas cause any damage to the lining of the colon, how far up the colon the enemas travel after they are given, and how much study participants like using each of the enemas.
Detailed description
Research participants who are deemed eligible after screening will return for a baseline evaluation. The baseline visit includes clinical evaluation and colon tissue collection, as well as a Baseline Behavioral Questionnaire (BBQ). The BBQ will be administered by Computer Assisted Self-Interview (CASI). Participants may complete the web-based CASI in the privacy of their own home.
Following the baseline visit, participants will be randomized into one of three groups. Each group will receive enemas of varying osmolality (molecule concentrations) in a different sequence according to study stage. During each stage of enema test product use participants will receive a single inpatient dose followed by three outpatient doses to be used in the context of Receptive Anal Intercourse (RAI).
This study will involve 3 stages of enema test product use. Each stage is identical, with the exception of the enema osmolality. Each stage includes an inpatient period and an outpatient period. The time period between stages 1, 2, and 3 will be approximately 2-6 weeks to allow for a recovery period, opportunities for product use, and appointment availability. The participant's inpatient portion of the study will take place as scheduling permits after the at-home enema use is complete.
During each stage, the participant is admitted to the inpatient unit for <48 hours, placed on a clear liquid diet, and has an interval medical history and directed physical exam. The following day the 125ml study enema is radiolabeled and administered to the participant. Over an approximately 25 hour time period, the participant will undergo pharmacokinetic studies involving blood drawing, colon tissue sample collection by flexible sigmoidoscopy, and imaging by Single Photon Emission Computed Tomography/ paired with x-ray Computed Tomography (SPECT/CT). The participant will then be discharged home with 3 doses of study enema. Participants will be instructed to allow for an approximately 72 hour recovery period (to ensure healing of the colon tissue biopsy sites) prior to initiating use of the study product on an outpatient basis, if applicable. Subjects will be encouraged to use the study product on 3 separate occasions in the context of RAI. As with standard HIV counseling, participants will be encouraged to use condoms. After each outpatient use the subject will complete a Brief Acceptability Questionnaire (BAQ). Then at the end of each stage of enema test article use, the subject will complete a Product Acceptability Questionnaire (PAQ).
Study Exit Interview At completion of all 3 stages the participant will complete an Overall Product Preference Questionnaire (OPPQ) administered by CASI followed by and in-depth interview.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Fleet Enema, Drug: tap water enema, Drug: Normosol-R enemaTap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home(Stage 2), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3) |
| B | Experimental | Drug: Fleet Enema, Drug: tap water enema, Drug: Normosol-R enemaNormosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3) |
| C | Experimental | Drug: Fleet Enema, Drug: tap water enema, Drug: Normosol-R enemaFleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Normosol-R enema(iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male
- ≥ Age of 18
- HIV-1 status antibody negative as documented at screening
- A history of RAI at least twice per month in the prior 3 months*
- History of enema use prior to RAI at least some of the time
Key exclusion criteria (14 listed)
- Female
- HIV positive at baseline
- History of inflammatory bowel disease
- Active inflammatory condition of the GI tract at baseline
- Active rectal infection at Visit 2 (Infections identified during the screening period must be treated prior to Visit 2)
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 |
|---|---|---|
| Fleet EnemaAlso: hyperosmolar enemahyper-osmolar preparation | Drug | A, B, C |
| tap water enemaAlso: hypo-osmolar enemahypo-osmolar preparation | Drug | A, B, C |
| Normosol-R enemaAlso: iso-osmolar enemaiso-osmolar preparation | Drug | A, B, C |
Primary outcome
Mucosal Toxicity Using Histopathology
Time frame: One hour following enema exposure
Endoscopy will be performed to obtain biopsy specimens at baseline and following each inpatient enema exposure. Samples will be obtained at each flexible sigmoidoscopy and set aside for batch sectioning and H\&E staining. Slides will be reviewed and scored by a qualified pathologist blinded to treatment assignment using a qualitative scoring system. This scoring system uses semi-quantitative scoring that focuses on acute toxicity to epithelial cell layer similar to that seen in animal studies. This is a categorical grading scale, where 0 = Epithelial surface intact;1 = <1/3 of surface denuded; 2 = 1/3 - 2/3rds of surface denuded;3 = More than 2/3rds of surface denuded. Six separate biopsies for each subject and each treatment intervention were analyzed in a multi-level analysis. In comparison with the baseline condition (no intervention), the odds and 95% confidence interval (CI) of having a higher epithelial denudation score were calculated for each intervention.
2 secondary outcomes
Radiolabel Area Under the Curve (AUC 0-24 hr)
Time frame: 24 hours following each intervention
D(Average) at Two Hours
Time frame: two hours following dosing of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Craig Hendrix, MD principal investigator
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 study testing Fleet Enema, tap water enema and Normosol-R enema 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 14 inclusion and 14 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 28 Apr 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mucosal Toxicity Using Histopathology (time frame: One hour following enema exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2017.