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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
  Purpose

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.


Condition Intervention
Human Immunodeficiency Virus (HIV)
 Other: Autologous seminal fluid with Tc-99m/In-111 radiolabels
Other: Autologous lymphocytes labeled with In-111 in normosol vehicle with TC-99m DTPA incorporated

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Seminal Fluid on Distal Colon Mucosal Permeability and Susceptibility to HIV Infection

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • HIV explant challenge [ Time Frame: Up to 14 days following ex vivo challenge ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Autologous seminal fluid with Tc-99m/In-111 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.
Placebo Comparator: Normosol vehicle
Autologous lymphocytes radiolabeled with In-111 suspended in Normosol-R vehicle with Tc-99m DTPA incorporated
 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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053741

Locations
United States, Maryland
Johns Hopkins University Drug Development Unit
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
amfAR, The Foundation for AIDS Research
Investigators
Principal Investigator: Edward Fuchs, PA-C, MBA Johns Hopkins University
  More Information

No publications provided

Responsible Party: Edward Fuchs, PA-C, MBA, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01053741     History of Changes
Other Study ID Numbers: NA_00014051
Study First Received: January 20, 2010
Last Updated: January 20, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Technetium Tc 99m Pentetate
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013