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

Completed · Not applicable

Conditions studied: Human Immunodeficiency Virus (HIV)

In brief

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.

Key facts

Study ID

NCT01053741

Run by

Johns Hopkins University

People needed

11

Starts

2008-03-01

Expected to finish

2009-12-01

Last updated by the study team

2017-05-25

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: accepted.

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.

Where it is running

• Johns Hopkins University Drug Development Unit — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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