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

This study has been completed.
Sponsor:
Collaborator:
amfAR, The Foundation for AIDS Research
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01053741
First received: January 20, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 20, 2010
January 20, 2010
March 2008
December 2009   (final data collection date for primary outcome measure)
  • Epithelial disruption [ Time Frame: One hour ] [ Designated as safety issue: Yes ]
  • Mucosal permeability to an incorporated radioisotope as measured in plasma and urine [ Time Frame: up to 4 hours following dosing ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
HIV explant challenge [ Time Frame: Up to 14 days following ex vivo challenge ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Human Immunodeficiency Virus (HIV)
  • Other: Autologous seminal fluid with Tc-99m/In-111 radiolabels
    Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle.
  • Other: Autologous lymphocytes labeled with In-111 in normosol vehicle with TC-99m DTPA incorporated
    Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle.
  • Active Comparator: Autologous seminal fluid with Tc-99m/In-111
    Intervention: Other: Autologous seminal fluid with Tc-99m/In-111 radiolabels
  • Placebo Comparator: Normosol vehicle
    Autologous lymphocytes radiolabeled with In-111 suspended in Normosol-R vehicle with Tc-99m DTPA incorporated
    Intervention: Other: Autologous lymphocytes labeled with In-111 in normosol vehicle with TC-99m DTPA incorporated
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Able to provide signed informed consent
  2. Men of 21 years or older.
  3. Prior history of receptive anal intercourse.
  4. Laboratory values within the last 28 days:

    • Negative for HIV antibodies
    • Lymphocyte count within normal limits
    • Neutrophil count > 1,000 cells/ml
    • CD4 > 500 cells/ml
    • Platelet count ≥ 150,000 cells/mm3
    • PT within normal limits
    • PTT within normal limits.
  5. No childbearing intentions.

Exclusion Criteria:

  1. Active anorectal disease or recent (3 months) anorectal surgery;
  2. Diarrhea, defined as three or more loose stools per day, for at least three days prior to admission.
  3. History of sleep apnea, or airway problems with previous sedation procedures.
  4. History of significant adverse reaction to sedation medications.
  5. 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.
Male
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01053741
NA_00014051
Yes
Edward Fuchs, PA-C, MBA, Johns Hopkins University
Johns Hopkins University
amfAR, The Foundation for AIDS Research
Principal Investigator: Edward Fuchs, PA-C, MBA Johns Hopkins University
Johns Hopkins University
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP