L-Carnitine to Treat Fatigue in AIDS Patients - Full Text View

Sponsor:	National Institute of Nursing Research (NINR)
Information provided by:	National Institute of Nursing Research (NINR)
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 Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Phase II Developmental Study on Fatigue in AIDS Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Carnitine

U.S. FDA Resources

Further study details as provided by National Institute of Nursing Research (NINR):

Primary Outcome Measures:

Level of fatigue, measured by the fatigue sub-scale of the FAHI [ Time Frame: Baseline; 2 weeks since starting L-carnitine or Placebo supplementation; 4 weeks (study termination) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in fatigue in the treatment and control groups [ Time Frame: Baseline; 2 weeks since starting L-carnitine or Placebo supplementation; 4 weeks (study termination) ] [ Designated as safety issue: No ]
Changes in cognative status, mood, activity, and HGB levels mesured by BFI, LASA, KPS, and MSAS-SF [ Time Frame: Baseline; 2 weeks since starting L-carnitine or Placebo supplementation; 4 weeks (study termination) ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	November 2002
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: L-carnitine A study drug, L-carnitine, titrating the doses from 0.5 g to 3 g to reduce the possibility of side effects, lasting for two weeeks followed by an extension phase where all patients recieved L-carnitine for an additional two weeks.
2: Placebo Comparator	Other: Placebo A placebo, where patients underwent the dose titration identical to the study patients, lasting for two weeeks followed by an extension phase where all patients recieved L-carnitine for an additional two weeks.

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
New York, New York, United States, 10003

Sponsors and Collaborators

National Institute of Nursing Research (NINR)

Investigators

Principal Investigator:

Ricardo Cruciani, MD, PhD

Beth Israel Medical Center

More Information

No publications provided

Responsible Party:	Beth Israel Medical Center ( Ricardo Cruciani, MD, PHD, Vice-Chairman, Department of Pain and Palliative Care, Director, Research Division )
Study ID Numbers:	1 R21 NR08295-01
Study First Received:	March 9, 2004
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00079599 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Nursing Research (NINR):

Carnitine Deficiency
Fatigue
Complementary Therapies

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Vitamin B Complex
Slow Virus Diseases
Immune System Diseases
Growth Substances
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Infection
Pharmacologic Actions

Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Vitamins
Sexually Transmitted Diseases
Lentivirus Infections
Micronutrients
Retroviridae Infections
Carnitine

ClinicalTrials.gov processed this record on November 27, 2009