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Search / Trial NCT00572429

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

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Dec 12, 2007

Trial Information

Current as of September 06, 2025

Withdrawn

Keywords

Hiv/Aids Haart High Cholesterol Exercise L Carnitine Complimentary Therapies

ClinConnect Summary

The introduction of Highly Active AntiRetroviral Therapy (HAART) for AIDS and HIV has improved survival considerably. However, HIV patients treated with HAART show significant metabolic symptoms, such as lipodystrophy, dyslipidemia, and insulin resistance. A possible contribution to these dysmetabolic symptoms in HIV/HAART is a decrease in mitochondrial function, resulting in a decreased fatty acid oxidation. Life style modulation such as aerobic exercise and L-carnitine supplementation may be beneficial to mitochondrial function. Aerobic exercise improves the biogenesis and function of mit...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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.

About University Of California, Davis

The University of California, Davis (UC Davis) is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials and studies. With a strong focus on interdisciplinary collaboration, UC Davis leverages its extensive expertise in medical research, education, and patient care to drive breakthroughs in various fields, including medicine, public health, and agriculture. The university's clinical trial programs emphasize rigorous scientific methodology and ethical standards, aiming to translate research findings into impactful treatments and improved patient outcomes. Through its state-of-the-art facilities and a dedicated team of researchers and healthcare professionals, UC Davis is at the forefront of transforming healthcare practices and addressing critical health challenges.

Locations

Sacramento, California, United States

Patients applied

0 patients applied

Trial Officials

Lars Berglund, MD, PhD

Principal Investigator

UC Davis Health System

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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