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L-Carnitine to Treat Fatigue in AIDS Patients

This study is currently recruiting participants.
Verified by National Center for Complementary and Alternative Medicine (NCCAM), April 2004

Sponsored by: National Institute of Nursing Research (NINR)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00079599
  Purpose

Patients with AIDS may develop a deficiency of the micronutrient carnitine and such a deficiency may contribute to fatigue in these patients. This study will determine whether carnitine supplementation will improve fatigue and related symptoms in carnitine-deficient patients with AIDS.


Condition Intervention Phase
HIV Infections
AIDS
Drug: L-carnitine
Phase II

MedlinePlus related topics:   AIDS  

ChemIDplus related topics:   Carnitine  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Phase II Developmental Study on Fatigue in AIDS Patients

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:   44
Study Start Date:   November 2002

Detailed Description:

Fatigue is a commonly reported symptom in patients with end stage AIDS. Appropriate treatment can relieve suffering and improve quality of life. The role of progression of the disease, depression, anemia, and poor nutritional status in the development of fatigue is well recognized. However, the impact of micronutrient deficiencies has been minimally explored. AIDS patients are at risk for micronutrient deficiencies because of decreased caloric intake, increased metabolic requirements, and treatment with medications that can interfere with absorption, synthesis, and excretion. Patients with AIDS are particularly likely to be carnitine deficient.

Levocarnitine (L-carnitine) is a micronutrient found in meat and dairy products that plays a major role in energy metabolism. Preliminary research has shown that patients with end stage AIDS experienced decreased levels of fatigue after L-carnitine supplementation. This study will evaluate the effectiveness of L-carnitine to treat patients with carnitine deficiency, fatigue, and AIDS.

Participants in this study will be randomly assigned to receive either L-carnitine or placebo for 2 weeks. To reduce the possibility of side effects, the doses of L-carnitine and placebo will be titrated over 6 days to the desired study dose. After 2 weeks, participants receiving placebo will be switched over to receive L-carnitine. All participants will continue on L-carnitine for an additional 2 weeks.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • AIDS at Stage IV-C and estimated life expectancy < 6 months
  • Karnofsky Performance Score > 50
  • Clinically significant, persistent fatigue
  • If undergoing pre-existing treatment for fatigue, must have been on a stable regimen for at least 4 weeks prior to study entry
  • Concurrent use of epoetin alfa (PROCRIT®) will be allowed if the patient has been on a stable dose of epoetin alfa for at least 60 days prior to study entry

Exclusion Criteria:

  • Severe cardiovascular, pulmonary, or renal function
  • Hemodialysis
  • Treatment or replacement therapy with any form of carnitine within 12 months prior to study entry
  • Known sensitivity to carnitine
  • Acute illness within 30 days of study entry that in the opinion of the study investigator would interfere with participation
  • Active drug or alcohol use or dependence
  • History of any central nervous system disease involving the brain that may put the patient at risk for seizure (e.g., primary or metastatic brain tumor, stroke) or history of seizure
  • History of dementia, aphasia, or other deficits of cognition or speech/language function
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079599

Locations
United States, New York
Department of Pain Medicine and Palliative Care; Beth Israel Medical Center; First Avenue at 16th Street     Recruiting
      New York, New York, United States, 10003
      Contact: Ricardo Cruciani, MD; PhD     212-420-4748     rcrucian@bethisraelny.org    

Sponsors and Collaborators

Investigators
Principal Investigator:     Ricardo Cruciani, MD, PhD     Beth Israel Medical Center    
  More Information

Study ID Numbers:   1 R21 NR08295-01
First Received:   March 9, 2004
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00079599
Health Authority:   United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Carnitine Deficiency  
Fatigue  
Complementary Therapies  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Fatigue
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Carnitine
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Virus Diseases
RNA Virus Infections
Vitamin B Complex
Slow Virus Diseases
Immune System Diseases
Growth Substances
Vitamins
Physiological Effects of Drugs
Lentivirus Infections
Micronutrients
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008




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