An interventional study of Radiolabeled autologous seminal fluid and Radiolabeled Normosol-R in Human Immunodeficiency Virus (HIV), sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to male participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-25.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Basic science
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.
Design of effective rectal microbicides to prevent HIV infection requires an understanding of rectal HIV transmission and the location within the lower gastrointestinal (GI) tract (luminal and mucosal) of HIV (cell-free and cell-associated) following exposure to infected seminal fluid. These basic details of HIV transmission have yet to be determined in human subjects, yet they are essential to select microbicide candidates if they are to be rationally designed to achieve effective concentrations at sites of HIV transmission. Rational development of a rectal microbicide also requires an understanding of those factors that may contribute to colonic mucosal injury - potential confounders of microbicidal effect. Such factors include exposure to seminal fluid which has been shown in animal and in vitro studies to cause histologic and permeability changes that might facilitate HIV transmission.
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This study's enrollment of 11 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
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Exclusion Criteria:
2.5 mL radiolabeled autologous seminal fluid administered rectally x1. Two week pause between interventions. Then 2.5 mL radiolabeled Normosol-R administered rectally X1.
Biological: Radiolabeled autologous seminal fluid · Biological: Radiolabeled Normosol-R
2.5 mL radiolabeled Normosol-R administered rectally x1. Two week pause between interventions. Then 2.5 mL radiolabeled autologous seminal fluid administered rectally X1.
Biological: Radiolabeled autologous seminal fluid · Biological: Radiolabeled Normosol-R
Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle.
Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle.
Epithelial Disruption Graded by a Pathologist Blinded to Study Intervention.
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.
Time frame: One hour
Recruitment initiated September 2008, completed October 2009. Study participants recruited from previous trial participation and advertisements posted in the medical institutions.
| Milestone | Seminal Fluid, Then Normosol-R | Normosol-R Then Seminal Fluid |
|---|---|---|
| Started | 5 | 6 |
| Completed | 5 | 6 |
| Not completed | 0 | 0 |
| Milestone | Seminal Fluid, Then Normosol-R | Normosol-R Then Seminal Fluid |
|---|---|---|
| Started | 5 | 6 |
| Completed | 5 | 6 |
| Not completed | 0 | 0 |
| Milestone | Seminal Fluid, Then Normosol-R | Normosol-R Then Seminal Fluid |
|---|---|---|
| Started | 5 | 6 |
| Completed | 5 | 5 |
| Not completed | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 |
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.
| units on a scale | Seminal Fluid | Normosol-R |
|---|---|---|
| Epithelial Disruption Graded by a Pathologist Blinded to Study Intervention. | 1.0 (0.92 to 1.17) | 1.17 (1.04 to 1.46) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Seminal Fluid | — | 0/10 (0%) | 4/10 (40%) |
| Normosol-R | — | 0/10 (0%) | 3/10 (30%) |
| Event | Seminal Fluid | Normosol-R |
|---|---|---|
| Gas/bloatingGastrointestinal disorders | 4/10 | 3/10 |
| Age, Continuous(years) | Seminal Fluid Then Normosol | Normosol-R Then Seminal Fluid | Total |
|---|---|---|---|
| Median | 44 (34 to 50) | 40 (21 to 48) | 41.5 (21 to 50) |
| Sex/Gender, Customized(Participants) | Seminal Fluid Then Normosol | Normosol-R Then Seminal Fluid | Total |
|---|---|---|---|
| Male gender | 5 | 5 | 10 |
| Region of Enrollment(participants) | Seminal Fluid Then Normosol | Normosol-R Then Seminal Fluid | Total |
|---|---|---|---|
| United States | 5 | 5 | 10 |
Plan to share: No — This is an exploratory physiologic study.
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Johns Hopkins University