L-Carnitine to Treat Fatigue in AIDS Patients

This study has been completed.
Sponsor:
Information provided by:
National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:
NCT00079599
First received: March 9, 2004
Last updated: September 2, 2008
Last verified: September 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Developmental Study on Fatigue in AIDS Patients

Resource links provided by NLM:


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
Experimental: 1 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.
Placebo Comparator: 2 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
Investigators
Principal Investigator: Ricardo Cruciani, MD, PhD Beth Israel Medical Center
  More Information

No publications provided

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

Keywords provided by National Institute of Nursing Research (NINR):
Carnitine Deficiency
Fatigue
Complementary Therapies

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Fatigue
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Signs and Symptoms
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014