Status:
COMPLETED
L-Carnitine to Treat Fatigue in AIDS Patients
Lead Sponsor:
National Institute of Nursing Research (NINR)
Conditions:
HIV Infections
AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 supplementatio...
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, ane...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00079599
Start Date
November 1 2002
End Date
March 1 2007
Last Update
September 4 2008
Active Locations (1)
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1
Department of Pain Medicine and Palliative Care; Beth Israel Medical Center; First Avenue at 16th Street
New York, New York, United States, 10003