Low Dose Naltrexone to Treat Chronic Neuropathic Pain in Adults With HIV A Phase 4 Open-Label Clinical Trial Evaluating Pain Relief and Immune Response

What this Trial Is About

Researchers are evaluating the use of low-dose naltrexone LDN to treat chronic neuropathic pain in adults living with HIV who have some level of viral control but still experience pain. The study aims to explore whether LDN, an opioid antagonist used at lower doses as an immune modulator, can reduce pain and improve immune markers such as CD4 count. This study addresses the need for safer, more effective pain treatments in this population, given the limitations and side effects of chronic opioid use. Participants will either receive low-dose naltrexone starting at 3 mg daily for one week, increasing to 4 mg daily if tolerated, or be part of a control group without intervention. The medication is taken orally during the day to minimize side effects like sleep disturbances. The study lasts 12 weeks, during which participants pain scores and inflammatory markers are regularly assessed. Control group members will provide pain and symptom data remotely without in-person visits. During the study, participants will have their pain levels measured weekly using numerical rating scales and questionnaires, while blood tests will monitor inflammation and immune system markers at the start and end of the 12-week period. The study also tracks CD4 counts as part of routine care. Researchers will review changes in pain intensity, symptom scores, and biological markers to evaluate LDNs impact. Participants are followed closely through clinic visits or phone calls, and their safety and symptom changes are monitored throughout the study.

Low Dose Naltrexone for Pain in Patients With HIV