Expired Study
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New York, New York 10003


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.


Study summary:

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.


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


Study is Available At:


Original ID:

1 R21 NR08295-01


NCT ID:

NCT00079599


Secondary ID:


Study Acronym:


Brief Title:

L-Carnitine to Treat Fatigue in AIDS Patients


Official Title:

Phase II Developmental Study on Fatigue in AIDS Patients


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Nursing Research (NINR)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

44


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ricardo Cruciani, MD, PhD
Principal Investigator
Beth Israel Medical Center

Study Dates

Start Date:November 2002
Completion Date:March 2007
Completion Type:Actual
Primary Completion Date:March 2007
Primary Completion Type:Actual
Verification Date:September 2008
Last Changed Date:September 2, 2008
First Received Date:March 9, 2004

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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)
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:L-carnitine
Description: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.
Arm Name:1
Intervention Type:Other
Name:Placebo
Description: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.
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:Placebo Comparator
Arm Name:2

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Nursing Research (NINR)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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