Enema Use and Acceptability in HIV Negative Men Who Have Sex With Men
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV prevention, MSM, Enema, HIV Seronegativity
Eligibility Criteria
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.
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
A
B
C
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)
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)
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)