Liraglutide for HIV-associated Neurocognitive Disorder

What Was Tested

The trial (phase 4) is built around Liraglutide.

This study will test the effect of liraglutide on cognitive function in HIV-infected overweight or obese subjects with type 2 diabetes.

It had 1 arm (groups): Liraglutide (experimental).

The registry classes the interventions as drug.

More on the Plan

The study hypothesis is that GLP-1 could potentially ameliorate the impairments in cognition in this population.

This study will assess the impact of liraglutide on neurocognitive performance and peripheral inflammatory markers.

It will also evaluate the effects of liraglutide on glycemic control and metabolic risk factors in HIV infected subjects with type 2 diabetes.

Who Took Part

Enrollment: 4 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: HIV controlled on therapy for at least 12 weeks. Viral load \< 200 copies. BMI \>27 to 45. Diagnosis of DM type 2 with A1-C \>7 to 15. Participants must be willing to comply with all study related procedures.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: personal or family history of pancreatitis; medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2); allergy to liraglutide or any of the active ingredients in liraglutide or other glp-1 analogue.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Liraglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-09 with completion listed for 2018-06-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile (time frame: 6 months). Neurocognitive performance- change in domain averages on a standard neuropsychological profile (time frame: 6 months).

It also tracked 16 secondary outcomes, for example Change from baseline high sensitivity C-reactive protein, Change from baseline d-dimer, Change from baseline Interleukin 6, Change from baseline plasma soluble cluster of differentiation 14 (CD14), Change from baseline BMI and Change from baseline weight.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Liraglutide in 4 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.