Actively Recruiting
Role of Endogenous Opioid Peptides in HIV-associated Chronic Widespread Pain
Led by Florida International University · Updated on 2026-01-14
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the causes of chronic widespread pain (CWP) in people living with HIV (PWH). CWP includes regional and widespread musculoskeletal pain of neuropathic and inflammatory types, leading to significant functional impairment. The study focuses on whether reduced production or release of natural opioid peptides by immune cells contributes to this pain, as current treatments have limited benefits and opioid use raises concerns about addiction and overdose. Participants will be randomly assigned to receive either saline or RELISTOR, a drug that blocks peripheral opioid receptors, in two visits spaced 5 to 7 days apart. Dosage of RELISTOR depends on participant weight, ranging from 8 mg to 12 mg or 0.15 mg/kg. The study involves four groups based on HIV status and presence of chronic pain to compare opioid peptide effects. During the study visits, participants will undergo quantitative sensory testing (QST) to assess pain sensitivity before and after receiving the study drug or placebo. Pain questionnaires and blood samples to measure opioid peptides in plasma and immune cells will also be collected. These measures help researchers evaluate the relationship between opioid peptides and pain sensitivity. The study period includes baseline and follow-up assessments, with participant involvement lasting through these two visits.
CONDITIONS
Brief Title
Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed HIV diagnosis and currently a patient in the UAB 1917 HIV Clinic
- Age 19 to 65 years
- People living with HIV must be receiving stable antiretroviral therapy
- Non-HIV participants must be confirmed HIV negative
- HIV-negative participants with chronic widespread pain must report bodily pain more than once per week for at least three consecutive months
- HIV-negative participants without chronic pain must report no pain or pain less frequently than once per week for at least three consecutive months
You will not qualify if you...
- Anemia
- Current or past history of blood disorders increasing hemolysis
- Active infections affecting blood inflammatory cells
- Use of medications other than antiretroviral therapy that conflict with study observations, except stable pain management medications excluding methadone or buprenorphine
- Systemic rheumatic diseases like rheumatoid arthritis or systemic lupus erythematosus
- Cachexia and severe frailty
- History of significant surgery in the past year
- Uncontrolled hypertension (SBP/DBP >150/95) or cardiovascular/peripheral arterial disease
- Poorly controlled diabetes (HbA1c >8%)
- Neurological diseases (e.g., Parkinson's, multiple sclerosis, epilepsy)
- Serious psychiatric disorders requiring hospitalization in past 12 months or active suicidal ideation
- Cognitive impairment interfering with study understanding
- Pregnancy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 1 to 2 weeks
Participants will be randomly administered either saline or RELISTOR, a peripherally acting opioid receptor antagonist, in a crossover design with two treatment visits separated by at least 5 to 7 days. Quantitative sensory testing and pain assessments will be completed before and after treatment administration.
2 treatment visits (in-person) at least 5 to 7 days apart
Trial Site Locations
Total: 1 location
1
Ambulatory Care Center, Florida International University
Miami, Florida, United States, 33199
Actively Recruiting
Research Team
S
Saurabh Aggarwal, MD., PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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