Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics

Conditions

• Chronic Widespread Pain

Eligibility Criteria

Sex

ALL

Age

19 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Relistor Injectable Product — DRUG
  Relistor is a peripherally acting opioid receptor antagonist approved by the FDA for relief of opioid-induced constipation

Study Details

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

Key Dates

Start date

Nov 15, 2021

Status verified

Jan 2026

Primary completion

Jul 30, 2026

Completion

Jul 30, 2026

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: HIV negative without chronic widespread pain
  50 Participants will be randomly administered saline or RELISTOR (Individuals weighing 38-\<62 kg will receive an 8 mg dose; those weighing 62-114 kg will receive a 12 mg dose; Participants weighing more than 114 kg will receive 0.15 mg/kg) in counterbalance between visit 1 and visit 2.
• Experimental: HIV negative with chronic widespread pain
  50 Participants will be randomly administered saline or RELISTOR (Individuals weighing 38-\<62 kg will receive an 8 mg dose; those weighing 62-114 kg will receive a 12 mg dose; Participants weighing more than 114 kg will receive 0.15 mg/kg) in counterbalance between visit 1 and visit 2.
• Experimental: HIV positive without chronic widespread pain
  50 Participants will be randomly administered saline or RELISTOR (Individuals weighing 38-\<62 kg will receive an 8 mg dose; those weighing 62-114 kg will receive a 12 mg dose; Participants weighing more than 114 kg will receive 0.15 mg/kg) in counterbalance between visit 1 and visit 2.
• Experimental: HIV positive with chronic widespread pain
  50 Participants will be randomly administered saline or RELISTOR (Individuals weighing 38-\<62 kg will receive an 8 mg dose; those weighing 62-114 kg will receive a 12 mg dose; Participants weighing more than 114 kg will receive 0.15 mg/kg) in counterbalance between visit 1 and visit 2.

Primary Outcome Measure

Quantitative sensory testing (QST) [ Time Frame: At baseline (study visit 1) ]

Central Contacts

• Saurabh Aggarwal, MD., PhD
  305-348-9634
  [email protected]

Locations (1)

Find similar trials in Miami, FL

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