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

What Was Tested

This registered not phased trial tested L-Carnitine.

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).

The researchers 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.

It had two arms (groups): 1 (active comparator) and 2 (placebo comparator).

L-carnitine.

Placebo.

The registry classes the interventions as dietary supplement and other.

More on the Plan

The postprandial state is a proinflammatory and proatherogenic condition.

The researchers have experience from postprandial studies in HAART-treated HIV-positive African American and Hispanic subjects, where the researchers have focused on the relationship between lipids, fatty acids, insulin and adipokines.

This is of particular relevance among African Americans, where key metabolic components differ substantially from levels in Caucasians.

Further, the relationship between metabolic parameters and HIV/HAART is far less explored in this ethnic group.

Who Took Part

The registry lists 13 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men and Women Ages 18-70,. Stable HAART regimen x 6 mo,. PI or NNRTI based regimens,. Caucasian, African American or Hispanic patients.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: diabetes mellitus,; liver disease,uncontrolled; pregnant or nursing mothers,.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant and investigator.

It started in 2006-10 with completion listed for 2009-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example L-carnitine will impact upon the relationship between insulin and NEFA or adipokines in the postprandial state.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 13 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.