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NCT01053741 · ClinicalTrials.gov registry record · NA
Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission
A NA study of Human Immunodeficiency Virus (HIV), sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT01053741: Completed NA study of Human Immunodeficiency Virus (HIV), sponsored by Johns Hopkins University.
NCT01053741 is a NA study of Human Immunodeficiency Virus (HIV) that has completed, run by Johns Hopkins University. The registered enrollment target is 11 participants, below the 508-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01053741, a NA study of Human Immunodeficiency Virus (HIV), has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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. T
Conditions Studied
Interventions
- BIOLOGICAL Radiolabeled autologous seminal fluid
- BIOLOGICAL Radiolabeled Normosol-R
Study Locations (1)
Maryland
- Johns Hopkins University Drug Development Unit - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-12 |
| Phase | NA |
What the finished NCT01053741 record still lists
NCT01053741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 508-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Human Immunodeficiency Virus (HIV) appearing as the primary indexed condition, and to 2 interventions - of which Radiolabeled autologous seminal fluid is the first listed.
NCT01053741 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01053741 about?
NCT01053741 is a clinical study titled "Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission". 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.
What is the current status of trial NCT01053741?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2008-03. Estimated completion is 2009-12.
What conditions does trial NCT01053741 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus (HIV).
What interventions are being tested in trial NCT01053741?
The interventions under investigation include: Radiolabeled autologous seminal fluid (BIOLOGICAL), Radiolabeled Normosol-R (BIOLOGICAL).
Who is sponsoring clinical trial NCT01053741?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01053741 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01053741's enrollment target sits among peer trials
11 19th of 18 the lowest of 18 other Human Immunodeficiency Virus (HIV) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Immunodeficiency Virus (HIV) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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