Lactate Metabolism Study in HIV Infected Persons

What Was Tested

This registered phase 4 trial tested L-Carnitine.

Although acidosis is rare, hyperlactatemia is common and may have long term consequences yet to be recognized.

Lactic acidosis is a manifestation of mitochondrial toxicity; consequences which have yet to be fully recognized and understood.

It had four arms (groups): 1 (experimental), 2 (experimental), 3 (experimental) and 4 (experimental).

Individuals living with HIV who are on an antiretroviral regimen including one of D4T/ddI/ddC/AZT.

Individuals living with HIV who are on an antiretroviral regimen including one of D4T/ddI/ddC/AZT and have liver disease.

The registry classes the interventions as drug.

More on the Plan

Toxicities are often metabolic and include hyperlipidemia, hyperglycemia, osteopenia and lipodystrophy.

The consequences of chronic hyperlactatemia are not well understood, but it is known that the cause is likely related to mitochondrial toxicity of nucleoside analogues, which are the cornerstone class of HIV therapies.

Some of this liver dysfunction could also be attributable to mitochondrial toxicity.

The researchers will also study a subset of HIV infected persons with known underlying liver disease.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Participants at least 18 years of age or older either:. HIV negative, or. HIV positive, not on antiretroviral therapy (for at least 6 months) or. HIV positive, on D4T/ddC/ddI/AZT containing HAART or. HIV positive, on D4T/ddC/ddI/AZT containing HAART, with hepatic steatosis/liver disease.

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: active aids defining illness; known poor adherence with therapy; end stage renal disease.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Everyone knew when L-Carnitine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2002-07 with completion listed for 2008-10.

It ran at 1 site in Canada.

Its stated primary purpose is health services research.

What Was Measured

Primary outcome: Changes in lactate clearance pre and post supplementation (time frame: two months).

It also tracked 2 secondary outcomes, for example Evidence of adverse response to supplements and/or antiretroviral medications.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of L-Carnitine in 30 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.