Combination of an Investigational Cannabinoid and Methadone for HIV-associated Neuropathy

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: HIV-associated Neuropathy, Polyneuropathy

In brief

The purpose of this study is to evaluate the effectiveness of methadone alone and in combination with SAB378 for the treatment of painful HIV-associated neuropathy.

Key facts

Study ID

NCT00723918

Run by

Washington University School of Medicine

People needed

0

Starts

2009-04-01

Expected to finish

2010-01-01

Last updated by the study team

2018-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infection
• HIV-associated neuropathy diagnosed by a neurologist
• Presence of at least a moderate pain score on the basis of completion of a baseline pain diary
• Stable antiretroviral regimen for at least 8 weeks prior to study entry.
• Hemoglobin ≥ 8.0 g/dL for males and ≥ 7.5 g/dL for females

You may not qualify if…

• Active AIDS-defining opportunistic infection within 45 days prior to study entry
• Renal insufficiency
• Chronic liver disease
• B12 deficiency
• Family history of hereditary neuropathy
• Discontinuation of dideoxynucleoside NRTI within 16 weeks prior to entry
• On neuroregenerative therapy
• Treatment with neurotoxic drugs within 120 days prior to entry
• Respiratory compromise
• Hypotension
• Active substance abuse or dependence
• History of alcohol-related complications within 6 months prior to screening
• Women of childbearing potential

Where it is running

• University of California, San Diego — San Diego, California, United States
• University of New York Downstate Medical Center — Brooklyn, New York, United States
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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