|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Johns Hopkins University |
|---|---|
| Collaborator: |
University of California, Los Angeles |
| Information provided by: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00696618 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Fleets enema Drug: tap water enema Drug: Normosol-R enema |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| 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) |
| Enrollment: | 9 |
| Study Start Date: | July 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Fleets enema
hyper-osmolar preparation
|
| Experimental: B |
Drug: tap water enema
hypo-osmolar preparation
|
| Experimental: C |
Drug: Normosol-R enema
iso-osmolar preparation
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A history of RAI at least twice per month in the prior 3 months*
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
| Principal Investigator: | Craig Hendrix, MD | Johns Hopkins University |
More Information
| Responsible Party: | Craig Hendrix, MD, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00696618 History of Changes |
| Other Study ID Numbers: | NA_00010972 |
| Study First Received: | June 4, 2008 |
| Last Updated: | August 3, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
HIV prevention MSM Enema HIV Seronegativity |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Sodium phosphate Cathartics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |