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Home > "A" Clinical Trials Conditions > Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy  Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy
Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy
For Condition: HIV Infections,Peripheral Nervous System Diseases
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Neurologic AIDS Research Consortium (NARC)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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 - Onset or worsening of neuropathic symptoms must have been associated with the initiation or dose escalation of one or more dideoxynucleoside analogues - 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 - 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.
Total Enrollment: 36
Location and Contact Information:
Overall Study Official:
VictorValcour, Study Chair, University of Hawaii
Northwestern Univ
Chicago, Illinois, 60611-3015
United States
Baiba Berzins 312-695-5012
Univ of Texas, Southwestern Med Ctr
Sacramento, California, 95814
United States
Chip Lohner 214-590-0414
The Cornell Clinical Trials Unit
New York City, New York, 10021
United States
Valery Hughes 212-746-4393
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Washington (Seattle)
Seattle, Washington, 90033-1079
United States
Jeanne Conley 206-731-8877
Beth Israel Med Ctr
New York City, New York, 10003
United States
Ann Marshak 212-420-4432
Univ of Texas, Galveston
Galveston, Texas, 77555-0435
United States
Carrie Derkowski 409-747-0241
Stanford Univ
Stanford, California, 94305
United States
Debbie Slamowitz 650-723-2804
Johns Hopkins University
Baltimore, Maryland, 21287-8106
United States
Ilene Wiggins 410-614-2766
Cook County Hosp Core Ctr
Chicago, Illinois, 60612
United States
Joanne Despotes 312-572-4545
Additional Information:
Study ID Numbers: ACTG A5157;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050271
Other Peripheral Nervous System Diseases Studies:
1. A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
2. Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
3. A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
4. Tolerability of Three Local Anesthetic Formulations in Conjunction with NGX-4010 for the Treatment of Neuropathic Pain
5. A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients
Related Studies:
Other Peripheral Nervous System Diseases Clinical Trials
Other California Clinical Trials
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Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy
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