Liraglutide for HIV-associated Neurocognitive Disorder

Phase 4TerminatedNCT02743598

Temple University4 enrolled

Overview

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

HIV, insulin resistance and type 2 diabetes mellitus (DM) are independently associated with cognitive impairment. Considering the synergistic effects of HIV and DM on cognition, these subjects are at increased risk of cognitive impairment. glucagon-like peptide 1 (GLP-1) receptors have wide tissue distribution including the central nervous system. 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infection Diabetes Mellitus Type 2 Obesity Overweight Metabolic Syndrome

Interventions

LiraglutideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Personal or family history of pancreatitis * Medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2) * Gastroparesis * Allergy to liraglutide or any of the active ingredients in liraglutide or other GLP-1 analogue * Weight loss drugs other than metformin * Type 1 diabetes mellitus or diabetic ketoacidosis * Known major cognitive deficit dementia, history of head trauma with loss of consciousness \>30 min, history of stroke, current central nervous system (CNS) disorder such as seizures or opportunistic CNS infection * Renal insufficiency defined as creatinine clearance \< 60 mL/min * Active opportunistic infections * Pregnancy or breastfeeding * Unstable cardiovascular disease with hospitalization within 1 year for acute coronary syndrome * Decompensated heart failure * Substance abuse * Active alcohol or opioid substitution therapy * Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation

Locations (1)

Cherie Vaz

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Change from baseline high sensitivity C-reactive protein

Time frame: 3 and 6 months

Change from baseline d-dimer

Time frame: 3 and 6 months

Change from baseline Interleukin 6

Time frame: 3 and 6 months

Change from baseline plasma soluble cluster of differentiation 14 (CD14)

Time frame: 3 and 6 months

Change from baseline BMI

Time frame: 3 and 6 months

Change from baseline weight

Time frame: 3 and 6 months

Change from baseline waist circumference

Time frame: 3 and 6 months

Change from baseline blood pressure

Time frame: 3 and 6 months

Change from baseline serum triglycerides

Time frame: 3 and 6 months

Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR) in subjects not on insulin

Data from ClinicalTrials.gov

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