NCT01053741

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

The Effect of Seminal Fluid on Distal Colon Mucosal Permeability and Susceptibility to HIV Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Accepted

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)

Interventions

Type	Name	Description
BIOLOGICAL	Radiolabeled autologous seminal fluid	Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle.
BIOLOGICAL	Radiolabeled Normosol-R	Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2010-01-21
• Last updated: 2017-05-25
• Results posted: 2017-05-25

Locations

1 site across 1 country: United States