Effects of L-Carnitine on Postprandial Clearance of Triglyceride-rich Lipoproteins in HIV Patients on HAART

NCT00386971 | Completed

• 2 other identifiers: 200614280GCRC protocol 109
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Included in this study will be patients with HIV and being treated with highly active antiretroviral medications (HAART) including protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI). Protease inhibitors and non-nucleoside reverse transcriptase inhibitors are very common medications in HIV treatment and are usually given with other medications as part of a standard treatment for HIV (HAART). We hope to learn more about how the levels of cholesterol-and triglyceride-carrying particles (lipoproteins) are affected by a nutritional supplement, L-Carnitine, in HIV-positive patients treated with antiretroviral medications.

Conditions

Hyperlipidemia; HIV Infections

Keywords

L-carnitine; HIV; TGRL metabolism; postprandial; HIV Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• L-carnitine supplementation will improve fasting TGRL levels and the postprandial response

  6 weeks

Secondary Outcomes (1)

• L-carnitine will impact upon the relationship between insulin and NEFA or adipokines in the postprandial state

  6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

L-carnitine

Dietary Supplement: L-carnitine

2

PLACEBO COMPARATOR

Placebo

Other: placebo

Interventions

L-carnitine DIETARY_SUPPLEMENT

3 grams daily in liquid form by mouth

1

placebo OTHER

1 oz sweet tasting liquid daily by mouth

2

Eligibility Criteria

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

You may qualify if:

• Men and Women Ages 18-70,
• Stable HAART regimen x 6 mo,
• PI or NNRTI based regimens,
• Caucasian, African American or Hispanic patients

You may not qualify if:

• Diabetes Mellitus,
• Liver Disease,uncontrolled
• Pregnant or nursing mothers,
• BMI\> 35,
• Hemoglobin \<11 g/dl,
• Conditions known to lower seizure threshold (ie. brain tumor) or taking medications that lower seizure threshold,
• Patients taking: Warfarin, ValproicAcid or Zidovudine,Wellbutrin or Effexor
• Chronic Kidney Disease Stage 3-5,
• Untreated Thyroid Disease,
• Hormone replacement therapy,
• Triglycerides \>500 mg/dl (fasting)

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

GCRC UC Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Hyperlipidemias; HIV Infections

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; 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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Lars Berglund, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 12, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (1)