Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics
ConditionChronic Widespread Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorFlorida International University
About this trial
To determine if decreased production or release of endogenous opioid peptides by peripheral immune cells contributes to hypersensitivity in people with HIV
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Confirmed HIV diagnosis and currently a patient in the UAB 1917 HIV Clinic
Age 19 - 65; the lower end of this age range was chosen to capture young adults with HIV infection, and participants over 65 years are increasingly likely to meet one or more
Disqualifiers
All people living with HIV must be currently receiving stable antiretroviral therapy (ART) for inclusion in this study
Non-HIV participants must be confirmed as HIV negative. HIV-negative participants with chronic widespread pain must self-report bodily pain more than once per week for at least three consecutive months and HIV-negative participants without chronic pain must self-report no pain, or pain less frequently than once per week for at least three consecutive months
Anemia
Current or past history of blood disorders which may increase hemolysis
Trial design
Design model
Crossover
Treatments tested in this trial
Relistor Injectable Product
DrugRelistor is a peripherally acting opioid receptor antagonist approved by the FDA for relief of opioid-induced constipation
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: HIV negative without chronic widespread painExperimental treatment 1 intervention
Group B: HIV negative with chronic widespread painExperimental treatment 1 intervention
Group C: HIV positive without chronic widespread painExperimental treatment 1 intervention
Group D: HIV positive with chronic widespread painExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Quantitative sensory testing (QST)
Measured at baseline and 30 min post intervention to assess change in response. (0=no pain, 100=most pain) * Heat Pain - 1) A slowly increasing heat stimulus (44°C, 46°C, and 48°C) will be delivered; 2) a series of 5 heat pulses (about 2 sec) will be given and pain will be rated (0-100) * Touch Test Pain. Von Frey filament will be tapped on knee and hand and asked to rate the pain (0-100) after a single tap, and after 10 consecutive taps * Pressure Pain Threshold. A slowly increasing pressure will be applied on forearm and shoulder with a probe (Algomed) till pain is felt. Then constant pressure will be applied till the sensation first becomes painful to assess threshold in kilopascals * Combined Pressure and Cold Pain. Hand will be immersed in cold water (10°C). After 30 sec, pain intensity will be rated (0-100). Hand will be kept in cold water for another 30 sec and then the pressure pain test will be performed, and first instance of pain due to pressure will be assessed
Time frame
At baseline (study visit 1)2
Quantitative sensory testing (QST)
Measured at baseline and 30 min post intervention to assess change in response. (0=no pain, 100=most pain) * Heat Pain - 1) A slowly increasing heat stimulus (44°C, 46°C, and 48°C) will be delivered; 2) a series of 5 heat pulses (about 2 sec) will be given and pain will be rated (0-100) * Touch Test Pain. Von Frey filament will be tapped on knee and hand and asked to rate the pain (0-100) after a single tap, and after 10 consecutive taps * Pressure Pain Threshold. A slowly increasing pressure will be applied on forearm and shoulder with a probe (Algomed) till pain is felt. Then constant pressure will be applied till the sensation first becomes painful to assess threshold in kilopascals * Combined Pressure and Cold Pain. Hand will be immersed in cold water (10°C). After 30 sec, pain intensity will be rated (0-100). Hand will be kept in cold water for another 30 sec and then the pressure pain test will be performed, and first instance of pain due to pressure will be assessed
Time frame
Study visit 2 will occur at least 5-7 days after the first visitSecondary outcomes
1
McGill Pain Questionnaire-Short Form
15 descriptors (11 sensory; 4 affective) using an intensity scaled ranging from 0-3 on pain scale (0 = no pain, 1 = mild pain, 2 = moderate pain or 3 = severe pain)
Time frame
At baseline (study visit 1)2
McGill Pain Questionnaire-Short Form
15 descriptors (11 sensory; 4 affective) using an intensity scaled ranging from 0-3 on pain scale (0 = no pain, 1 = mild pain, 2 = moderate pain or 3 = severe pain)
Time frame
Study visit 2 will occur at least 5-7 days after the first visit3
Measuring endogenous opioid peptides in plasma and peripheral leukocytes
20 ml blood will be drawn to isolate plasma and peripheral leukocytes
Time frame
At baseline (study visit 1)Sponsors and contacts
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Source ClinicalTrials.gov