Clinical trial NCT00079599: L-Carnitine to Treat Fatigue in AIDS Patients
Official title: Phase II Developmental Study on Fatigue in AIDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
AIDS
Keywords: Carnitine Deficiency
Fatigue
Complementary Therapies
Lead sponsor: National Institute of Nursing Research (NINR)
Sponsor class: NIH
First posted: 2004-03-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 supplementation will improve fatigue and related symptoms in carnitine-deficient patients with AIDS.

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 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

Primary outcomes:
measure: Level of fatigue, measured by the fatigue sub-scale of the FAHI
timeFrame: Baseline; 2 weeks since starting L-carnitine or Placebo supplementation; 4 weeks (study termination)
Secondary outcomes:
measure: Changes in fatigue in the treatment and control groups
timeFrame: Baseline; 2 weeks since starting L-carnitine or Placebo supplementation; 4 weeks (study termination)
measure: Changes in cognative status, mood, activity, and HGB levels mesured by BFI, LASA, KPS, and MSAS-SF
timeFrame: Baseline; 2 weeks since starting L-carnitine or Placebo supplementation; 4 weeks (study termination)
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Pain Medicine and Palliative Care; Beth Israel Medical Center; First Avenue at 16th Street
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Ricardo Cruciani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: