- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00696618
Enema Use and Acceptability in HIV Negative Men Who Have Sex With Men
A Randomized, Blinded, Comparative Study of the Mucosal Toxicity, Colorectal Distribution, and Participant Acceptability of Three Different Preparatory Enemas (Hypo-, Iso-, and Hyper-osmolar)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.)
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
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)
|
hyper-osmolar preparation
Other Names:
hypo-osmolar preparation
Other Names:
iso-osmolar preparation
Other Names:
|
Experimental: B
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)
|
hyper-osmolar preparation
Other Names:
hypo-osmolar preparation
Other Names:
iso-osmolar preparation
Other Names:
|
Experimental: C
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)
|
hyper-osmolar preparation
Other Names:
hypo-osmolar preparation
Other Names:
iso-osmolar preparation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
One hour following enema exposure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiolabel Area Under the Curve (AUC 0-24 hr)
Time Frame: 24 hours following each intervention
|
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
|
24 hours following each intervention
|
D(Average) at Two Hours
Time Frame: two hours following dosing of intervention
|
Mean proximal residence distance of radio-signal from anus as measured on SPECT/CT
|
two hours following dosing of intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Plasma-lyte 148
Other Study ID Numbers
- NA_00010972
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Fleet Enema
-
NorgineCompletedColorectal CancerUnited Kingdom
-
NorgineCompleted
-
Istanbul Bakirkoy Maternity and Children Diseases...Approved for marketingPostoperative Bowel Sounds | Bowel Gass PassageTurkey
-
University of North Carolina, Chapel HillCompletedLaparoscopic Hysterectomy and/or Laparoscopic SacrocolpopexyUnited States
-
Nova Scotia Health AuthorityRecruiting
-
H. Lee Moffitt Cancer Center and Research InstituteCompletedProstate CancerUnited States
-
Taipei Medical University Shuang Ho HospitalCompleted
-
Chiang Mai UniversityPrapaporn SuprasertCompletedOther Surgical Procedures | Cathartic ColonThailand
-
London North West Healthcare NHS TrustCompletedAnastomotic Leak | Ulcerative Colitis | Ileal PouchUnited Kingdom
-
Nabiqasim Industries (Pvt) LtdDow University of Health SciencesUnknownIrritable Bowel SyndromePakistan