Actively Recruiting

Phase Not Applicable
Age: 19Years - 65Years
All Genders
Healthy Volunteers
NCT04787848

Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics

Led by Florida International University · Updated on 2026-01-14

200

Participants Needed

1

Research Sites

245 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To determine if decreased production or release of endogenous opioid peptides by peripheral immune cells contributes to hypersensitivity in people with HIV

CONDITIONS

Official Title

Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics

Who Can Participate

Age: 19Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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 currently receiving stable antiretroviral therapy
  • HIV-negative 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
Not Eligible

You will not qualify if you...

  • Anemia
  • Current or past history of blood disorders that may increase hemolysis
  • Active microbial infections affecting blood inflammatory cells
  • Use of medications other than antiretroviral therapy that might interfere, except stable pain management drugs (excluding methadone or buprenorphine for opioid addiction)
  • Systemic rheumatic diseases such as rheumatoid arthritis or lupus
  • Cachexia (wasting syndrome) and severe frailty
  • Clinically significant surgery within the past year
  • Uncontrolled hypertension (SBP/DBP >150/95) or cardiovascular or peripheral arterial disease
  • Poorly controlled diabetes (HbA1c > 8%)
  • Neurological diseases like Parkinson's, multiple sclerosis, epilepsy
  • Serious psychiatric disorder requiring hospitalization within past 12 months or active suicidal ideation
  • Active suicidal risk at screening
  • Cognitive impairment affecting understanding of study procedures
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ambulatory Care Center, Florida International University

Miami, Florida, United States, 33199

Actively Recruiting

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Research Team

S

Saurabh Aggarwal, MD., PhD

CONTACT

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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