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Pain and Sensory Changes Assessment in HIV+ Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00422695
First received: January 16, 2007
Last updated: March 2, 2017
Last verified: January 2017
Results First Received: March 9, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: HIV Infections

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
HIV + Groups divided according to CD4 counts 105 HIV subjects
Healthy Controls HIV -free subjects 38 Healthy Controls

Participant Flow:   Overall Study
    HIV +   Healthy Controls
STARTED   105   38 
COMPLETED   105   38 
NOT COMPLETED   0   0 



  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.
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Reporting Groups
  Description
HIV + Groups divided according to CD4 counts
Healthy Controls HIV -ve subjects
Total Total of all reporting groups

Baseline Measures
   HIV +   Healthy Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 105   38   143 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      105 100.0%      38 100.0%      143 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.97  (7.22)   42.53  (12.57)   45.06  (8.64) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      42  40.0%      14  36.8%      56  39.2% 
Male      63  60.0%      24  63.2%      87  60.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      97  92.4%      35  92.1%      132  92.3% 
White      7   6.7%      3   7.9%      10   7.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   1.0%      0   0.0%      1   0.7% 
Region of Enrollment 
[Units: Participants]
     
United States   105   38   143 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome   [ Time Frame: Tests were performed during regular clinical visit. The test duration was about an hour ]

2.  Primary:   Spontaneous Pain Intensity   [ Time Frame: The time of the examination ]


  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
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  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: Eli Eliav
Organization: Rutgers School of Dental Medicine
phone: 973 972 7210
e-mail: eliavel@sdm.rutgers.edu



Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00422695     History of Changes
Other Study ID Numbers: 0120060172
Study First Received: January 16, 2007
Results First Received: March 9, 2016
Last Updated: March 2, 2017