Pain and Sensory Changes Assessment in HIV+ Patients

NCT00422695 | Completed Results

• 1 other identifier: 0120060172
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.
• To determine psychological condition and nutrition status in patients with HIV.
• To find associations between inherited traits and development of neuropathic pain.

Conditions

HIV Infections

Keywords

HIV; Quantitative Sensory Testing; Neuropathy; Treatment Experienced; Treatment Naive

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome

  1. To investigate the prevalence of orofacial pain in HIV infected patients during routine dental clinical assessment. 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.

  Tests were performed during regular clinical visit. The test duration was about an hour

• Spontaneous Pain Intensity

  Pain intensity as measured with Visual Analog Scale during the time of examination. The subjects were required to report their perceived level of pain on a 10 cm VAS scale from zero to 10 with zero being no pain and 10 representing the worst pain imaginable. Given the ease of use of this method and its current use to measure pain, VAS scales were adapted to measure patient perceived orofacial pain wherein subjects were asked to draw a vertical line at the point on the horizontal line which best represented their pain response. Where left 0 is no pain and right -10 is maximal pain.

  The time of the examination

Study Arms (2)

HIV +

Groups divided according to CD4 counts

Healthy Controls

HIV -ve subjects

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV +ve subjects Healthy Controls

You may qualify if:

• 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.

You may not qualify if:

• Patients under 18 year of age.
• Pregnant women.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

New Jersey Dental School

Newark, New Jersey, 07101, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Samples

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Eli Eliav
• Organization: Rutgers School of Dental Medicine

eliavel@sdm.rutgers.edu

973 972 7210

Study Officials

• Eli Eliav, DMD PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 17, 2007
• Study Start: January 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: April 13, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)