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

NCT00572429 | Withdrawn

• 1 other identifier: 200715081
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections; Hyperlipidemia; Exercise

Keywords

HIV/AIDS; HAART; high cholesterol; exercise; L-carnitine; Complimentary therapies

Outcome Measures

Primary Outcomes (1)

• Exercise and L-carnitine supplementation will reduce blood lactate levels, increase the VO2sub-max and the VLDL to leucine enrichment ratio in HIV/HAART patients, suggesting an overall improvement of muscle and hepatic mitochondrial function.

  6 weeks

Study Arms (1)

A

PLACEBO COMPARATOR

Dietary Supplement: l-carnitine

Interventions

l-carnitine DIETARY_SUPPLEMENT

3 gram daily dose

A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

CARES

Sacramento, California, 95814, United States

Location

MeSH Terms

Conditions

HIV Infections; Hyperlipidemias; Motor Activity; Acquired Immunodeficiency Syndrome; Hypercholesterolemia

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Lars Berglund, MD, PhD

  UC Davis Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 13, 2007
• Study Start: July 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 19, 2012

Record last verified: 2012-12

Locations

US (1)