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The Effect of Seminal Fluid on Distal Colon Mucosal Permeability and Susceptibility to HIV Infection
This research is being done to learn how seminal fluid affects the lining of the colon, and whether this might make it easier for HIV to get into the body and cause infection.
Details
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 11 |
| Start date | 2008-03 |
| Completion | 2009-12 |
Conditions
- Human Immunodeficiency Virus (HIV)
Interventions
- Radiolabeled autologous seminal fluid
- Radiolabeled Normosol-R
Primary outcomes
- Epithelial Disruption Graded by a Pathologist Blinded to Study Intervention. — One hour
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.
Countries
United States