L-Carnitine to Treat Fatigue in AIDS Patients

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Nursing Research (NINR)

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