HIV InfectionPhase 4NCT02743598
Liraglutide for HIV-associated Neurocognitive Disorder
A Phase 4 study testing Liraglutide in people with HIV Infection and Diabetes Mellitus Type 2, run by Temple University at 1 site in United States.
Trial summary
This study will test the effect of liraglutide on cognitive function in HIV-infected overweight or obese subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infection, Diabetes Mellitus Type 2, Obesity
- What is being tested?
- Liraglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Sep 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Liraglutide on Cognition, Chronic Inflammation and Glycemic Control in Overweight and Obese, HIV-infected Subjects With Type 2 Diabetes.
This study will test the effect of liraglutide on cognitive function in HIV-infected overweight or obese subjects with type 2 diabetes.
Read the 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.
- Conditions
- HIV Infection, Diabetes Mellitus Type 2, Obesity, Overweight, Metabolic Syndrome
- Being tested
- Liraglutide
- Keywords
- HIV infection, Diabetes Mellitus type 2, Obesity, Neurocognitive function
- Medical subject headings
- HIV Infections, Diabetes Mellitus, Type 2, Obesity, Overweight, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | Not described Receives: Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile
Measured: 6 months
Neurocognitive performance- change in domain averages on a standard neuropsychological profile
Measured: 6 months
Secondary outcomes (16)
Change from baseline high sensitivity C-reactive protein
Measured: 3 and 6 months
Change from baseline d-dimer
Measured: 3 and 6 months
Change from baseline Interleukin 6
Measured: 3 and 6 months
Change from baseline plasma soluble cluster of differentiation 14 (CD14)
Measured: 3 and 6 months
Change from baseline BMI
Measured: 3 and 6 months
Change from baseline weight
Measured: 3 and 6 months
Change from baseline waist circumference
Measured: 3 and 6 months
Change from baseline blood pressure
Measured: 3 and 6 months
Change from baseline serum triglycerides
Measured: 3 and 6 months
Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR) in subjects not on insulin
Measured: 3 and 6 months
Change from baseline liver enzymes aspartate aminotransferase and alanine aminotransferase
Measured: 3 and 6 months
Change from baseline Hemoglobin A1c
Measured: 3 and 6 months
Change from baseline fructosamine
Measured: 3 and 6 months
Number of Adverse events
Measured: 3 and 6 months
Number of subjects with Adverse events
Measured: 3 and 6 months
Change from baseline serum LDL
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startSep 2016
- Primary completion1 Jun 2018
- Study completionSep 2018
Why it stopped: Lack of funding and time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- The Comprehensive NeuroAIDS Center (CNAC) at Temple University
- Responsible party
- Sponsor
- Investigators
- Cherie Vaz, MD Dipl ABOM, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743598
- Sponsor's protocol ID
- 23284
- Status last verified
- Jul 2022
- First submitted
- 7 Apr 2016
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Liraglutide on Cognition, Chronic Inflammation and Glycemic Control in Overweight and Obese, HIV-infected Subjects With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT02743598
- Acronym / sponsor ID
- 23284
- Conditions
- HIV Infection, Diabetes Mellitus Type 2, Obesity, Overweight, Metabolic Syndrome
- Keywords
- HIV infection, Diabetes Mellitus type 2, Obesity, Neurocognitive function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding and time
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- The Comprehensive NeuroAIDS Center (CNAC) at Temple University
- Study start
- Sep 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: Liraglutide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liraglutide | Drug | Liraglutide |
Primary outcome
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
16 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
Time frame: 3 and 6 months
Change from baseline liver enzymes aspartate aminotransferase and alanine aminotransferase
Time frame: 3 and 6 months
Change from baseline Hemoglobin A1c
Time frame: 3 and 6 months
Change from baseline fructosamine
Time frame: 3 and 6 months
Number of Adverse events
Time frame: 3 and 6 months
Number of subjects with Adverse events
Time frame: 3 and 6 months
Change from baseline serum LDL
Time frame: 3 and 6 months
Results and safety
The study was stopped early (reason given: Lack of funding and time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cherie Vaz, MD Dipl ABOM principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide in people with HIV Infection and Diabetes Mellitus Type 2, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding and time). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.