Liraglutide for HIV-associated Neurocognitive Disorder (NCT02743598) | Clinical Trial Compass
TerminatedPhase 4
Liraglutide for HIV-associated Neurocognitive Disorder
Stopped: Lack of funding and time
United States4 participantsStarted 2016-09
Plain-language summary
This study will test the effect of liraglutide on cognitive function in HIV-infected overweight or obese subjects with type 2 diabetes.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile
Timeframe: 6 months
2
Neurocognitive performance- change in domain averages on a standard neuropsychological profile