Liraglutide for HIV-associated Neurocognitive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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HIV Infection Diabetes Mellitus Type 2 Obesity Overweight Metabolic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liraglutide

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

Interventions

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Liraglutide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No