N/A
N=11
Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission
Human Immunodeficiency Virus (HIV)
Bottom Line
View on ClinicalTrials.gov: NCT01053741 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Epithelial Disruption Graded by a Pathologist Blinded to Study Intervention. — 1.0; 1.17 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiolabeled autologous seminal fluid (Biological); Radiolabeled Normosol-R (Biological)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Male
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Epithelial Disruption Graded by a Pathologist Blinded to Study Intervention. |
1.0; 1.17 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Able to provide signed informed consent
- Men of 21 years or older.
- Prior history of receptive anal intercourse.
- Laboratory values within the last 28 days:
- Negative for HIV antibodies
- Lymphocyte count within normal limits
- Neutrophil count > 1,000 cells/ml
- Cluster of Differentiation 4 (CD4) cell count > 500 cells/ml
- Platelet count ≥ 150,000 cells/mm3
- Prothrombin Time (PT) within normal limits
- Partial thromboplastin time (PTT) within normal limits.
- No childbearing intentions.
Exclusion Criteria
- Active anorectal disease or recent (3 months) anorectal surgery;
- Diarrhea, defined as three or more loose stools per day, for at least three days prior to admission.
- History of sleep apnea, or airway problems with previous sedation procedures.
- History of significant adverse reaction to sedation medications.
- Other history, including significant occupational radiation exposure, history of inflammatory bowel disease or any other diseases and lab results, such that, in the judgment of the investigator, study procedures are not considered safe for the subject's participation.
Data sourced from ClinicalTrials.gov (NCT01053741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.