Status:
WITHDRAWN
Combination of an Investigational Cannabinoid and Methadone for HIV-associated Neuropathy
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
HIV-associated Neuropathy
Polyneuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Distal sensory polyneuropathy is the most common neurological complication of HIV disease and its treatment. To date no standard effective therapy has been identified. In this study, scientists will ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00723918
Start Date
April 1 2009
End Date
January 1 2010
Last Update
February 9 2018
Active Locations (3)
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1
University of California, San Diego
San Diego, California, United States, 92093
2
University of New York Downstate Medical Center
Brooklyn, New York, United States, 11208
3
University of Rochester
Rochester, New York, United States, 14620