Effects of Mixed Exercise Regime and L-Carnitine Supplementation in HIV Patients on HAART

Withdrawn before enrolling · Not applicable

Conditions studied: HIV Infections, Hyperlipidemia, Exercise

In brief

HIV patients treated with Highly Active AntiRetroviral Therapy (HAART) show significant metabolic symptoms, such as lipodystrophy, dyslipidemia, and insulin resistance. A possible contribution to these symptoms in HIV/HAART is a decrease in mitochondrial function, resulting in a decreased fatty acid oxidation. A combined regime of aerobic and resistance training has been demonstrated to increase lean body mass and reduce overall fat and truncal fat and the levels of triglyceride and LDL cholesterol.

Key facts

Study ID

NCT00572429

Run by

University of California, Davis

People needed

0

Starts

2008-07-01

Expected to finish

2010-12-01

Last updated by the study team

2012-12-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• African American, Hispanic and Caucasian adults with HIV on a stable HAART regimen (either PI or NNRTI based) for at least the past 6 months between 18 to 70 years of age.
• Patients taking SSRI's (Selective Serotonin Reuptake Inhibitors), SNRI's (Serotonin/Norepinephrine Reuptake inhibitors) and Tetracyclic antidepressants will be included as the risk of seizure in these patients in combination with the L-Carnitine supplement would be rare. Patients on these medications should be on a stable dose for at least 4-6 months prior to enrollment in the study.

You may not qualify if…

• Diabetes Mellitus
• Cushing's syndrome
• Renal disease (i.e. CKD Stages 3-5)
• Unstable liver disease
• Untreated thyroid dysfunction
• Seizure disorder
• Patients with conditions that can lower seizure threshold (i.e. brain tumors) or are taking medication(s) known to lower seizure threshold
• Pregnant or nursing mothers
• BMI > 35
• Ongoing hormone replacement therapy
• Hemoglobin levels less than 11 g/dl, and fasting triglyceride levels > 500 mg/dl.
• Subjects with ongoing hypolipidemic and warfarin therapy will be excluded. Additionally, patients taking Valproic Acid and / or Zidovudine will be excluded as these have been shown to deplete carnitine.
• Patients taking Venlafaxine and Bupropion will be excluded as these medications have a small risk (0.26% and 0.1-0.4% risk, respectively) of causing seizure in patients without a previous risk of seizure.

Where it is running

• CARES — Sacramento, California, United States

Full record on ClinicalTrials.gov

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