Trial record 20 of 26 for:    "Neuropathy" [CONDITION] AND HIV [CONDITION]

Pain and Sensory Changes Assessment in HIV+ Patients

This study has been completed.
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00422695
First received: January 16, 2007
Last updated: June 25, 2008
Last verified: June 2008
  Purpose

There are about 42 million people in the world afflicted with HIV or AIDS with about 1 million patients in the US.

The epidemiology of orofacial pain has been reported extensively in the literature, yet the prevalence severity and level of pain affecting the head, face, neck and intraoral structures has not been explored in a population of HIV infected individuals.

Pain, in general terms, is a common experience in HIV infected patients, even in the absence of cancer or opportunistic infections. There is a variation in the prevalence of pain in these individuals depending on the stage of disease, care setting, and study methods. The purpose of this study is:

  1. To investigate the prevalence of orofacial pain in HIV infected patients during routine dental clinical assessment.
  2. To study the sensory phenotype of HIV+ patients and healthy volunteers using Quantitative Sensory Testing:

    • To detect the presence of sensory aberrations in the orofacial complex;
    • To identify which nerve types are involved;
    • To identify the type of orofacial pain based on both sensory testing and clinical findings.
  3. To determine psychological condition and nutrition status in patients with HIV.
  4. To find associations between inherited traits and development of neuropathic pain.

Condition
HIV Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pain and Sensory Changes Assessment in HIV+ Patients, A Model for Pain and Sensory Changes Related Compromised Immune System.

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Estimated Enrollment: 160
Study Start Date: January 2007
Study Completion Date: May 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Patients and control volunteers will be recruited from the Oral medicine Post-graduate clinic at NJDS. Medical history will be taken and will include age, gender, ethnicity, current and past illnesses, current and past medications, blood reports (CD4 and CD8 counts) which have been obtained during routine medical assessment. The clinician will perform a clinical head and neck examination. The examination shall include an extra-oral, cranial nerve and temporomandibular joint (TMJ) examination, and muscle palpation. A thorough intraoral examination will be performed. Patients will be examined for pathologies of the oral mucosa, teeth and periodontium prior to their participation in the study. The evaluation findings will be reported using the Research Diagnostic Criteria for Temperomandibular disorders. The patient will note level of pain on Visual Analogue Scale if there is any pre-existing orofacial pain. Psychological screening and nutritional questionnaires will be completed by the patient.

Quantitative Sensory Testing will be conducted bilaterally on the face and intraorally on the tongue. Extraorally, the infraorbital and mental nerves regions will be tested bilaterally using thermal and electrical detection thresholds. Intraorally the tongue will be tested bilaterally for thermal and electrical detection threshold.

Many of the differences among people in the way they respond to symptomatic therapies and their individual risk of HIV+ patients with neuropathic pain may be affected by their genetic makeup. We will search for these kinds of associations between inherited traits and development of neuropathic pain in this study.

If the patient presents with evidence for pathologies that requires extraction of any molar (based on clinical and radiographic findings), the patient will be assessed 3 days, 8 days post-extraction and then after 3 weeks for thermal and electrical detection thresholds.

Inclusion criteria:

Group I n = 40 HIV+ with CD4+T cells/mm³ > 500 as determined by previous routine medical examination and from previous blood reports.

Group II n = 40 HIV+ with CD4+T cells/mm³ 200-499 as determined by previous routine medical examination and from previous blood reports.

Group III n = 40 HIV+ with CD4+T cells/mm³ < 200 as determined by previous routine medical examination and from previous blood reports.

Control Group n = 40 Healthy with normal blood reports, without dental pathologies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Group I n = 40 HIV+ with CD4+T cells/mm³ > 500 as determined by previous routine medical examination and from previous blood reports.

Group II n = 40 HIV+ with CD4+T cells/mm³ 200-499 as determined by previous routine medical examination and from previous blood reports.

Group III n = 40 HIV+ with CD4+T cells/mm³ < 200 as determined by previous routine medical examination and from previous blood reports.

Control Group n = 40 Healthy with normal blood reports, without dental pathologies.

Exclusion Criteria:

  • Patients under 18 year of age.
  • Pregnant women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422695

Locations
United States, New Jersey
New Jersey Dental School
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Eli Eliav, DMD PhD Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Eli Eliav, UMDNJ
ClinicalTrials.gov Identifier: NCT00422695     History of Changes
Other Study ID Numbers: 0120060172
Study First Received: January 16, 2007
Last Updated: June 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
HIV
Quantitative Sensory Testing
Neuropathy
Treatment Experienced
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014