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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 (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01053741
First received: January 20, 2010
Last updated: April 24, 2017
Last verified: April 2017
Results First Received: March 2, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Investigator);   Primary Purpose: Basic Science
Condition: Human Immunodeficiency Virus (HIV)
Interventions: Biological: Radiolabeled autologous seminal fluid
Biological: Radiolabeled Normosol-R

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment initiated September 2008, completed October 2009. Study participants recruited from previous trial participation and advertisements posted in the medical institutions.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Seminal Fluid, Then Normosol-R Subjects first received 2.5 mL radiolabeled autologous seminal fluid administered rectally x1. Than a two week pause between interventions. Followed by 2.5 mL radiolabeled Normosol-R administered rectally x1.
Normosol-R Then Seminal Fluid Subjects first received 2.5 mL radiolabeled Normosol-R administered rectally x1. Then a two week pause between interventions. Followed by 2.5 mL radiolabeled autologous seminal fluid administered rectally x1.

Participant Flow for 3 periods

Period 1:   1st Intervention
    Seminal Fluid, Then Normosol-R   Normosol-R Then Seminal Fluid
STARTED   5   6 
COMPLETED   5   6 
NOT COMPLETED   0   0 

Period 2:   14 Day Washout
    Seminal Fluid, Then Normosol-R   Normosol-R Then Seminal Fluid
STARTED   5   6 
COMPLETED   5   6 
NOT COMPLETED   0   0 

Period 3:   2nd Study Intervention
    Seminal Fluid, Then Normosol-R   Normosol-R Then Seminal Fluid
STARTED   5   6 
COMPLETED   5   5 
NOT COMPLETED   0   1 
Physician Decision                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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

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

Normosol-R 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.

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

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

Total Total of all reporting groups

Baseline Measures
   Seminal Fluid Then Normosol   Normosol-R Then Seminal Fluid   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   10 
Age 
[Units: Years]
Median (Full Range)
 44 
 (34 to 50) 
 40 
 (21 to 48) 
 41.5 
 (21 to 50) 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
     
Male gender   5   5   10 
Region of Enrollment 
[Units: Participants]
     
United States   5   5   10 


  Outcome Measures

1.  Primary:   Epithelial Disruption Graded by a Pathologist Blinded to Study Intervention.   [ Time Frame: One hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Associate Director, Drug Development Unit
Organization: Johns Hopkins School of Medicine
phone: (410)614-8762
e-mail: ejfuchs@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01053741     History of Changes
Other Study ID Numbers: NA_00014051
Study First Received: January 20, 2010
Results First Received: March 2, 2017
Last Updated: April 24, 2017