ALCAR Prophylaxis Study

What Was Tested

This registered phase 2 trial tested L-Carnitine.

In addition the safety and tolerability of Acetyl L-carnitine will be assessed.

The registry classes the interventions as drug.

Who Took Part

The registry lists 50 planned participants were the target.

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

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

Examples of who could join: Male or female, aged \> 18 years of age. HIV-1 infected as documented by a licensed HIV-1 antibody ELISA. Ability to assess level of pain and complete a pain log. Ability to understand and provide written informed consent to participation in this trial. Naïve to antiretroviral therapy.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: diminished ankle reflexes (compared to the knee) or absent ankle reflexes. or; subjects who in the investigator's opinion are unlikely to complete the 48 weeks trial period; previous treatment with any drug known to induce peripheral neuropathy, specifically excessive alcohol, isoniazid \& vincristine.

How the Study Was Run

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

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

It started in 2003-11.

It ran at 1 site in United Kingdom.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): The change from baseline in total area of Protein Gene Product (PGP) immunostaining on the epidermis at 48 weeks.

It also tracked 13 secondary outcomes, for example -Proportion of patients requiring analgesic agents, -Changes in the global assessments of pain by both subject and investigator, -Proportion of patients with HIV-1 RNA < 50 copies/ml at 24 and 48 weeks, -Proportion of patients with virological failure at 24 and 48 weeks, -Changes in CD4+ cell count from baseline after 24 and 48 weeks of treatment and -Time to discontinuation of the randomised treatment and reasons for this.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 50 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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