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

NCT ID: NCT01053741

Last Updated: 2017-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-12-31

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.

Detailed Description

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.

Conditions

Human Immunodeficiency Virus (HIV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Seminal Fluid then Normosol

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.

Group Type: EXPERIMENTAL

Radiolabeled autologous seminal fluid

Intervention Type: BIOLOGICAL

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

Radiolabeled Normosol-R

Intervention Type: BIOLOGICAL

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

Normosol then Seminal Fluid

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.

Group Type: EXPERIMENTAL

Radiolabeled autologous seminal fluid

Intervention Type: BIOLOGICAL

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

Radiolabeled Normosol-R

Intervention Type: BIOLOGICAL

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

Interventions

Radiolabeled autologous seminal fluid

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

Intervention Type: BIOLOGICAL

Radiolabeled Normosol-R

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

amfAR, The Foundation for AIDS Research

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Fuchs, PA-C, MBA

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University Drug Development Unit

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00014051

Identifier Type: -

Identifier Source: org_study_id