NCT00079599

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started Nov 2002

Typical duration for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

September 4, 2008

Status Verified

September 1, 2008

Enrollment Period

4.3 years

First QC Date

March 9, 2004

Last Update Submit

September 2, 2008

Conditions

HIV InfectionsAIDS

Keywords

Carnitine DeficiencyFatigueComplementary Therapies

Outcome Measures

Primary Outcomes (1)

  • Level of fatigue, measured by the fatigue sub-scale of the FAHI

    Baseline; 2 weeks since starting L-carnitine or Placebo supplementation; 4 weeks (study termination)

Secondary Outcomes (2)

  • Changes in fatigue in the treatment and control groups

    Baseline; 2 weeks since starting L-carnitine or Placebo supplementation; 4 weeks (study termination)

  • Changes in cognative status, mood, activity, and HGB levels mesured by BFI, LASA, KPS, and MSAS-SF

    Baseline; 2 weeks since starting L-carnitine or Placebo supplementation; 4 weeks (study termination)

Study Arms (2)

1

EXPERIMENTAL
Drug: L-carnitine

2

PLACEBO COMPARATOR
Other: Placebo

Interventions

L-carnitineDRUG

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.

1
PlaceboOTHER

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.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pain Medicine and Palliative Care; Beth Israel Medical Center; First Avenue at 16th Street

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeSystemic carnitine deficiencyFatigue

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Ricardo Cruciani, MD, PhD

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 9, 2004

First Posted

March 10, 2004

Study Start

November 1, 2002

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

September 4, 2008

Record last verified: 2008-09

Locations

US(1)