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Study identifier: NCT05537935 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Low Dose Naltrexone for Pain in Patients With HIV

Condition: Human Immunodeficiency Virus · Chronic Neuropathic Pain  ·  Sponsor: Emory University

PhasePhase 4
Planned participants60
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

The increased life expectancy of Patients Living With HIV/AIDS (PLWHA) has increased the need for therapies for chronic conditions, such as chronic pain. Pain in the HIV population is often refractory and ends up being treated with chronic opioids, which are associated with adverse effects, including hyperalgesia, constipation, and risk of overdose. Naltrexone is an opioid antagonist used in the treatment of alcohol and opioid use disorders. Low Dose Naltrexone (LDN), naltrexone at a much lower dose, is thought to be an immune modulator and has been associated with an increased CD4 count in PLWHA. Repurposing this medication is relatively inexpensive and has the potential to expand access to treatment for a painful condition experienced in PLWHA. While there are many case reports on the efficacy of LDN in symptom reduction, there are only a small number of clinical trials that specifically examine pain and symptom relief. This study will include patients who are not completely virologically controlled and will monitor the CD4 counts drawn as a part of routine care. If the CD4 count improves with LDN and with reduced symptoms, this could be a significant improvement in HIV therapy for symptom control. There have been studies showing cytokine reduction in fibromyalgia patients but they did not investigate the correlation with cytokines and pain relief. This study involves repurposing a drug used for substance use disorder to a medication with the potential to treat pain and im…

This description comes directly from the study's public registry record.

Talk to the study team

Anne M McKenzie-Brown, MD  ·  404-686-2410  ·  amckenz@emory.edu

Always discuss trial participation with your own doctor first.

Locations (3)

Grady Memorial HospitalAtlanta, Georgia, United StatesRecruiting
Emory Midtown HospitalAtlanta, Georgia, United StatesRecruiting
Emory University HospitalAtlanta, Georgia, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05537935