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Withdrawn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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sacramento, California, United States
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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