Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission

NCT01053741 | Completed Results DMC

• 1 other identifier: NA_00014051
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Immunodeficiency Virus (HIV)

Outcome Measures

Primary Outcomes (1)

• 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.

  One hour

Study Arms (2)

Seminal Fluid then Normosol

EXPERIMENTAL

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

Normosol then Seminal Fluid

EXPERIMENTAL

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

Interventions

Radiolabeled autologous seminal fluid BIOLOGICAL

Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle.

Normosol then Seminal Fluid; Seminal Fluid then Normosol

Radiolabeled Normosol-R BIOLOGICAL

Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle.

Normosol then Seminal Fluid; Seminal Fluid then Normosol

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• amfAR, The Foundation for AIDS Research: collaborator

Study Sites (1)

Johns Hopkins University Drug Development Unit

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Associate Director, Drug Development Unit
• Organization: Johns Hopkins School of Medicine

ejfuchs@jhmi.edu

(410)614-8762

Study Officials

• Edward Fuchs, PA-C, MBA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 21, 2010
• Study Start: March 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 25, 2017
• Results First Posted: May 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)