Characteristics of Baseline Mucosal Indices of Injury and Inflammation in Men For Use in Rectal Microbicide Trials
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
Study Overview
Brief Summary
Microbicides are drugs that destroy microbes such as viruses and bacteria. Rectal microbicides may be able to prevent transmission of HIV during anal intercourse. The purpose of this study is to obtain rectal samples from men to learn information that may be valuable in future clinical trials of rectal microbicides.
Detailed Description
Rectal microbicides to prevent HIV transmission are currently being developed in the hope that someday they will be widely used to prevent sexually transmitted HIV. This study will examine variables in male rectal tissue; this information may be useful for future rectal microbicide safety and efficacy studies. The study will evaluate the differences in rectal tissue from HIV infected or uninfected males who either engage in anal-receptive sex (men who sleep with men, or MSM) or do not have anal-receptive sex.
The study will last approximately 7 months, with 6 weeks of follow-up. There are four groups in this study. Groups 1 and 2 will enroll HIV uninfected men; Groups 3 and 4 will enroll HIV infected men. Groups 1, 3, and 4 will comprise MSM who engage in anal-receptive sex; Group 2 will comprise men who do not. Patients will provide medical and medication history, undergo a complete physical exam, and receive HIV counseling at screening. An anoscopy (examination of the anus, anal canal, and lower rectum) and blood draw will be conducted at screening, study entry, and Weeks 2 and 4. Rectal secretions will be collected and a sigmoidoscopy (an internal examination of the rectum, distal sigmoid colon, and large bowel using a small camera) will be performed at study entry and Weeks 2 and 4.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- •For HIV infected patients, 3 or more HSV-2 (herpes) outbreaks in the 12 months prior to screening or 1 or more HSV-2 outbreaks in the 6 months prior to screening
- •Active, serious infections (other than HIV) requiring parenteral antibiotic therapy within 15 days prior to screening
- •Inflammatory bowel disease (ulcerative colitis or Crohn's disease) or rectal cancer
- •Rectal surgery, including fistulectomy
- •Diagnosed bleeding disorder, including hemophilia, thrombocytopenia, impaired blood clotting, or current use of anticoagulants that, in the opinion of the investigator, would make participation in the study unsafe or complicate interpretation of study outcome data
- •Prosthetic heart valve or diagnosis of valve abnormality
- •Hemorrhoid surgery in the 6 months prior to screening
- •Bleeding hemorrhoids at screening or in the 6 weeks prior to study entry
- •Anal fistulae in the 6 weeks prior to study entry
- •Active diarrheal disease (greater than 3 times a day) or bleeding disorder
- •Rectal cultures positive for chlamydia or gonorrhea at screening or within 1 month prior to study entry
- •Unprotected anal intercourse in the 3 months prior to study entry
- •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 study requirements
- •Enrolled in any other clinical trial for the duration of their participation in HPTN 056