Enema Use and Acceptability in HIV Negative Men Who Have Sex With Men

NCT00696618 | Completed Results DMC

• 1 other identifier: NA_00010972
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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 each of the enemas.

Conditions

HIV Infections

Keywords

HIV prevention; MSM; Enema; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• 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.

  One hour following enema exposure

Secondary Outcomes (2)

• Radiolabel Area Under the Curve (AUC 0-24 hr)

  24 hours following each intervention

• D(Average) at Two Hours

  two hours following dosing of intervention

Study Arms (3)

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)

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)

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)

Drug: Fleet Enema; Drug: tap water enema; Drug: Normosol-R enema

Interventions

Fleet Enema DRUG

hyper-osmolar preparation

Also known as: hyperosmolar enema

A; B; C

tap water enema DRUG

hypo-osmolar preparation

Also known as: hypo-osmolar enema

A; B; C

Normosol-R enema DRUG

iso-osmolar preparation

Also known as: iso-osmolar enema

A; B; C

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

sodium phosphate

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Associate Director, Drug Development Unit
• Organization: Johns Hopkins School of Medicine

ejfuchs@jhmi.edu

(410)641-8762

Study Officials

• Craig Hendrix, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 13, 2008
• Study Start: July 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: March 1, 2012
• Last Updated: April 28, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)