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

• Status: Withdrawn
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Methadone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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