L-Carnitine to Treat Fatigue in AIDS Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV Infections, AIDS

In brief

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.

Key facts

Study ID

NCT00079599

Run by

National Institute of Nursing Research (NINR)

People needed

44

Starts

2002-11-01

Expected to finish

2007-03-01

Last updated by the study team

2008-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department of Pain Medicine and Palliative Care; Beth Israel Medical Center; First Avenue at 16th Street — New York, New York, United States

Full record on ClinicalTrials.gov

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