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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Neurologic AIDS Research Consortium (NARC) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00050271 |
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.
Condition | Intervention |
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HIV Infections Peripheral Nervous System Diseases |
Drug: Acetyl-L-carnitine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Dose-Escalation Pilot Study of Acetyl-L-Carnitine for the Treatment of Dideoxynucleoside-Associated Distal Symmetric Peripheral Neuropathy |
Estimated Enrollment: | 36 |
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).
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Univ of Texas, Southwestern Med Ctr | |
Sacramento, California, United States, 95814 | |
Stanford Univ | |
Stanford, California, United States, 94305 | |
University of California, San Diego Antiviral Research | |
San Diego, California, United States, 92103 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
Cook County Hosp Core Ctr | |
Chicago, Illinois, United States, 60612 | |
Northwestern Univ | |
Chicago, Illinois, United States, 60611-3015 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287-8106 | |
University of Maryland, Institute of Human Virology | |
Baltimore, Maryland, United States, 21201 | |
United States, Missouri | |
Washington University (St. Louis) | |
St. Louis, Missouri, United States, 63108-2138 | |
United States, New York | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
The Cornell Clinical Trials Unit | |
New York, New York, United States, 10021 | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
United States, Texas | |
Univ of Texas, Galveston | |
Galveston, Texas, United States, 77555-0435 | |
United States, Washington | |
Univ of Washington (Seattle) | |
Seattle, Washington, United States, 90033-1079 | |
Puerto Rico | |
.University of Puerto Rico | |
San Juan, Puerto Rico, 00936-5067 |
Study Chair: | Victor Valcour, M.D. | University of Hawaii |
Study Chair: | Russell Bartt, M.D. | Cook County Hospital and Rush-Presbyterian St. Luke's Medical Center |
Study ID Numbers: | ACTG A5157 |
Study First Received: | December 3, 2002 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00050271 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Acetylcarnitine Dideoxynucleosides Epidermis Biopsy |
Immunohistochemistry Nerve Fibers Treatment Experienced |
Antimetabolites Nootropic Agents Sexually Transmitted Diseases, Viral Vitamin B Complex Acquired Immunodeficiency Syndrome Trace Elements Dideoxynucleosides Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases |
Anti-Retroviral Agents Neuromuscular Diseases HIV Infections Vitamins Peripheral Nervous System Diseases Sexually Transmitted Diseases Micronutrients Retroviridae Infections Carnitine Acetylcarnitine |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Dideoxynucleosides Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Neuromuscular Diseases Therapeutic Uses Vitamins Micronutrients Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors Acetylcarnitine Nootropic Agents RNA Virus Infections Vitamin B Complex Immune System Diseases Growth Substances Nervous System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections |