Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Peripheral Nervous System Diseases
Intervention: Acetyl-L-carnitine (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s): Victor Valcour, M.D., Study Chair, Affiliation: University of Hawaii Russell Bartt, M.D., Study Chair, Affiliation: Cook County Hospital and Rush-Presbyterian St. Luke's Medical Center
Summary
The purpose of this study is to determine if acetyl-L-carnitine (ALC) reduces pain,
numbness, and tingling in the feet and legs of patients with nucleoside reverse
transcriptase inhibitor (NRTI)-associated peripheral neuropathy. Another purpose is to
determine if ALC is safe and tolerable in HIV patients who have taken certain anti-HIV
drugs.
Clinical Details
Official title: An Open-Label, Dose-Escalation Pilot Study of Acetyl-L-Carnitine for the Treatment of Dideoxynucleoside-Associated Distal Symmetric Peripheral Neuropathy
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Detailed description:
Distal symmetric peripheral neuropathy (DSPN) is the most frequent neurologic complication
of HIV infection and its treatments. NRTIs, particularly dideoxy-NRTIs, represent a
significant risk factor for developing neuropathy. To date, there are no effective
treatments for DSPN. Studies of nonneuronal tissues indicate a beneficial effect of ALC in
HIV-1 seropositive individuals, but the role of ALC levels in patients with DSPN is unclear.
Despite conflicting data, carnitine and its derivatives are still commonly used.
Patients will have a screening visit and visits at entry and Weeks 6, 12, 18, and 24.
Patients are required to fast (no food or drink except water) for 4-12 hours for the
screening visit, entry visit, and at Weeks 12 and 24. Targeted physical examinations, blood
chemistries, liver function tests, HIV-1 RNA, CD4/CD8 cell counts, hematology, and lactate
assessments will be done. Patients will also have a small skin biopsy at entry and Week 24.
Patients will begin with 1 tablet of ALC twice daily and escalate dosage to a target dose of
3 tablets daily. They will remain on the 3-tablet dose or a maximum tolerated dose for the
duration of the study (24 weeks).
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- HIV-1 infection
- Viral load <= 10,000 copies/ml within 60 days of entry
- On stable antiretroviral medication for 8 weeks prior to entry and plan on staying on
current regimen for the duration of the study
- Currently taking at least one dideoxynucleoside analogue. Patients discontinuing
their dideoxynucleoside analogues or changing their antiretroviral regimen after
entry will remain on study drug and continue with the study requirements and
evaluation visits.
- No significant systemic antiretroviral toxicity
- Evidence of predominantly sensory neuropathy, as determined from an examination by a
neurologist
- Ongoing neuropathy of any duration
- Negative pregnancy test performed at screening and within 24 hours of study entry
- Agree not to become pregnant or to impregnate; agree to use acceptable methods of
contraception
Exclusion Criteria:
- ALC or similar drug within 90 days of entry
- Active AIDS-defining opportunistic infection (OI) or OI-defining condition within 30
days prior to entry
- Any condition or history of any condition, other than that related to HIV infection
or antiretroviral therapy, that would add confusion to the diagnosis of
dideoxynucleoside analogue-associated DSPN
- Pregnancy or breast-feeding
- Active malignancy
- Seizure disorder or history of seizure within 90 days of entry
- Current or history of bipolar disorder
- Certain drugs within 30 days of study entry
- Addition of certain pain medication during the 60 days prior to study entry
- Allergy/sensitivity to study drug or its formulations
- Any condition that, in the opinion of the site investigator, would interfere with the
study requirements
- Myelopathy
- Use of investigational agents that are not FDA-approved within 30 days of study
entry, except when approved by the study chair. Investigational antiretroviral drugs
available through expanded access or through AACTG trials will be allowed if they do
not conflict with study criteria.
Locations and Contacts
Puerto Rico-AIDS CRS, San Juan 00936-5067, Puerto Rico
Stanford CRS, Palo Alto, California 94305, United States
The Ponce de Leon Ctr. CRS, Atlanta, Georgia 30308, United States
Univ. of Hawaii at Manoa, Leahi Hosp., Honolulu, Hawaii, United States
Cook County Hosp. CORE Ctr., Chicago, Illinois 60612, United States
Northwestern University CRS, Chicago, Illinois 60611-3015, United States
Johns Hopkins Adult AIDS CRS, Baltimore, Maryland 21287-8106, United States
Washington U CRS, St. Louis, Missouri 63108-2138, United States
Beth Israel Med. Ctr., ACTU, New York, New York 10003, United States
Weill Med. College of Cornell Univ., The Cornell CTU, New York, New York, United States
University of Washington AIDS CRS, Seattle, Washington 90033-1079, United States
Additional Information
Haga clic aquí para ver información sobre este ensayo clínico en español.
Related publications: Wulff EA, Wang AK, Simpson DM. HIV-associated peripheral neuropathy: epidemiology, pathophysiology and treatment. Drugs. 2000 Jun;59(6):1251-60. Review. Simpson DM, Katzenstein D, Haidich B, Millington D, Yiannoutsos C, Schifitto G, McArthur J; AIDS Clinical Trials Group Protocol 291/860 Study Team. Plasma carnitine in HIV-associated neuropathy. AIDS. 2001 Nov 9;15(16):2207-8. Polydefkis M, Yiannoutsos CT, Cohen BA, Hollander H, Schifitto G, Clifford DB, Simpson DM, Katzenstein D, Shriver S, Hauer P, Brown A, Haidich AB, Moo L, McArthur JC. Reduced intraepidermal nerve fiber density in HIV-associated sensory neuropathy. Neurology. 2002 Jan 8;58(1):115-9. Scarpini E, Sacilotto G, Baron P, Cusini M, Scarlato G. Effect of acetyl-L-carnitine in the treatment of painful peripheral neuropathies in HIV+ patients. J Peripher Nerv Syst. 1997;2(3):250-2.
Last updated: May 17, 2012
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