Liraglutide for HIV-associated Neurocognitive Disorder | NCT02743598

Studies
Liraglutide for HIV-associated Neurocognitive Disorder

NCT02743598

Sponsor

Temple University

Status

Terminated

Last Update Posted

Jul 29, 2022Actual

Enrollment

4Actual

Phase

Phase 4

Conditions

HIV Infection
Diabetes Mellitus Type 2
Obesity
Overweight
Metabolic Syndrome

Interventions

Liraglutide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding and time

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Jun 1, 2018Actual

Completion Date

Sep 2018Actual

First Submitted Date

Apr 7, 2016

First Submission Date that Met QC Criteria

Apr 14, 2016

First Posted Date

Apr 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2022

Last Update Posted Date

Jul 29, 2022Actual

Name	Class
The Comprehensive NeuroAIDS Center (CNAC) at Temple University	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Label	Type	Description	Intervention Names
Liraglutide	Experimental		Drug: Liraglutide

Name	Type	Description	Arm Group Labels	Other Names
Liraglutide	Drug		Liraglutide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile		6 months
Neurocognitive performance- change in domain averages on a standard neuropsychological profile		6 months

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline high sensitivity C-reactive protein		3 and 6 months
Change from baseline d-dimer		3 and 6 months
Change from baseline Interleukin 6

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Cherie Vaz, MD Dipl ABOM	Temple University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cherie Vaz		Philadelphia	Pennsylvania	19140	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D003924	Diabetes Mellitus, Type 2
D009765	Obesity
D050177	Overweight
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069450	Liraglutide

Ancestor Terms

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones

Browse Leaves

Not provided

Browse Branches

Not provided