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Liraglutide for HIV-associated Neurocognitive Disorder

Primary Purpose

HIV Infection, Diabetes Mellitus Type 2, Obesity

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Liraglutide

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV infection, Diabetes Mellitus type 2, Obesity, Neurocognitive function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cherie Vaz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liraglutide

Arm Description

Outcomes

Primary Outcome Measures

Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile

Neurocognitive performance- change in domain averages on a standard neuropsychological profile

Secondary Outcome Measures

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

Change from baseline weight

Change from baseline waist circumference

Change from baseline blood pressure

Change from baseline serum triglycerides

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

Change from baseline liver enzymes aspartate aminotransferase and alanine aminotransferase

Change from baseline Hemoglobin A1c

Change from baseline fructosamine

Number of Adverse events

Number of subjects with Adverse events

Change from baseline serum LDL

Full Information

NCT ID

NCT02743598

First Posted

April 7, 2016

Last Updated

July 27, 2022

Sponsor

Temple University

Collaborators

The Comprehensive NeuroAIDS Center (CNAC) at Temple University

1. Study Identification

Unique Protocol Identification Number

NCT02743598

Brief Title

Liraglutide for HIV-associated Neurocognitive Disorder

Official Title

Effects of Liraglutide on Cognition, Chronic Inflammation and Glycemic Control in Overweight and Obese, HIV-infected Subjects With Type 2 Diabetes.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

Lack of funding and time

Study Start Date

September 2016 (Actual)

Primary Completion Date

June 1, 2018 (Actual)

Study Completion Date

September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Temple University

Collaborators

The Comprehensive NeuroAIDS Center (CNAC) at Temple University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection, Diabetes Mellitus Type 2, Obesity, Overweight, Metabolic Syndrome

Keywords

HIV infection, Diabetes Mellitus type 2, Obesity, Neurocognitive function

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liraglutide

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Liraglutide

Primary Outcome Measure Information:

Title

Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile

Time Frame

6 months

Title

Neurocognitive performance- change in domain averages on a standard neuropsychological profile

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change from baseline high sensitivity C-reactive protein

Time Frame

3 and 6 months

Title

Change from baseline d-dimer

Time Frame

3 and 6 months

Title

Change from baseline Interleukin 6

Time Frame

3 and 6 months

Title

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

Time Frame

3 and 6 months

Title

Change from baseline BMI

Time Frame

3 and 6 months

Title

Change from baseline weight

Time Frame

3 and 6 months

Title

Change from baseline waist circumference

Time Frame

3 and 6 months

Title

Change from baseline blood pressure

Time Frame

3 and 6 months

Title

Change from baseline serum triglycerides

Time Frame

3 and 6 months

Title

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

Time Frame

3 and 6 months

Title

Change from baseline liver enzymes aspartate aminotransferase and alanine aminotransferase

Time Frame

3 and 6 months

Title

Change from baseline Hemoglobin A1c

Time Frame

3 and 6 months

Title

Change from baseline fructosamine

Time Frame

3 and 6 months

Title

Number of Adverse events

Time Frame

3 and 6 months

Title

Number of subjects with Adverse events

Time Frame

3 and 6 months

Title

Change from baseline serum LDL

Time Frame

3 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cherie Vaz, MD Dipl ABOM

Organizational Affiliation

Temple University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cherie Vaz

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Liraglutide for HIV-associated Neurocognitive Disorder

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