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Metformin for HIV Inflammation

Primary Purpose

HIV, Coronary Artery Disease

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
metformin extended release
Sponsored by
University of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV+
  • on suppressive ART stable for > 1 year
  • Age > 45 years
  • Ability and willingness to provide written informed consent

Exclusion Criteria:

  • Uncontrolled chronic medical condition or cancer
  • Acute illness within 2 weeks of entry
  • Diagnosis of diabetes or impaired fasting glucose
  • Chronic diarrhea
  • Known hypersensitivity or contraindication to metformin use
  • Hepatitis C co-infection
  • Serum B12 level below the reference normal range as listed by the commercial laboratory (Diagnostic Laboratory Services)
  • Pregnancy, or intent to become pregnant
  • Any immunomodulator, HIV vaccine, any other vaccine, or investigational therapy within 30 days of study entry.
  • Current or past history of coronary artery disease or congestive heart failure
  • Resting heart rate > 100 beats/min
  • Presence of conduction abnormalities or pathologic arrhythmia on EKG
  • The following lab values: Hemoglobin < 9.0 g/dL; Absolute neutrophil count < 1000/μL; Platelet count < 50,000/μL; and AST (SGOT) and ALT (SGPT) > 5x ULN
  • Calculated creatinine clearance (Cockcroft and Gault) < 60 ml/min
  • Patients over 450 lbs
  • History of iodine allergy or X-ray contrast allergy
  • History of allergy to metoprolol
  • Active or recent past history (within past 2 years) of illicit substance or alcohol use or abuse which, in the judgment of the Investigator, will interfere with the patient's ability to comply with the protocol requirements
  • Patients in whom there are other reasons that the CAC/CTA procedure is contra-indicated or who are at higher risk of adverse events
  • Patients, who, in the opinion of the Investigator, are unable to comply with the dosing schedule and protocol evaluation or for whom the study may not be advisable

Sites / Locations

  • Hawaii Center for AIDSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Metformin Treatment Arm

Observational Arm

Arm Description

500 mg metformin Extended Release tablets - one tablet daily increased at 4 weeks to 2 tablets (1000 mg) daily.

Observation only

Outcomes

Primary Outcome Measures

Coronary plaques by CT angiography
change in total numbers of atherosclerotic plaques detected in the coronary arteries

Secondary Outcome Measures

Monocyte subsets by multiparametric flow cytometry
change in numbers (cells/microliter of blood) of each monocyte subset (classical, intermediate, non-classical and transitional subsets)
Monocyte secretory function by intracellular cytokine staining release assay
Change in percent of monocytes secreting cytokine TNFalpha, percent secreting cytokine IL-6 and percent secreting cytokine IL-1beta
Sub-types of coronary plaques by CT angiography
Change in numbers of non-calcified atherosclerotic plaques detected in the coronary arteries; change in numbers of mixed plaques; change in numbers of calcified coronary plaques

Full Information

First Posted
February 9, 2015
Last Updated
March 3, 2015
Sponsor
University of Hawaii
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT02383563
Brief Title
Metformin for HIV Inflammation
Official Title
Open-Label, Randomized, 24-Week Pilot Study of Metformin vs Observation for Persistent Immune Activation in Chronic HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hawaii
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This proposal seeks to assess the impact of 24 weeks of metformin on non-calcified plaques and calcified plaques assessed by coronary CT angiography, and on whether these changes can be explained by metformin-induced phenotypic and secretory changes of monocytes.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin Treatment Arm
Arm Type
Active Comparator
Arm Description
500 mg metformin Extended Release tablets - one tablet daily increased at 4 weeks to 2 tablets (1000 mg) daily.
Arm Title
Observational Arm
Arm Type
No Intervention
Arm Description
Observation only
Intervention Type
Drug
Intervention Name(s)
metformin extended release
Primary Outcome Measure Information:
Title
Coronary plaques by CT angiography
Description
change in total numbers of atherosclerotic plaques detected in the coronary arteries
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Monocyte subsets by multiparametric flow cytometry
Description
change in numbers (cells/microliter of blood) of each monocyte subset (classical, intermediate, non-classical and transitional subsets)
Time Frame
24 weeks
Title
Monocyte secretory function by intracellular cytokine staining release assay
Description
Change in percent of monocytes secreting cytokine TNFalpha, percent secreting cytokine IL-6 and percent secreting cytokine IL-1beta
Time Frame
24 weeks
Title
Sub-types of coronary plaques by CT angiography
Description
Change in numbers of non-calcified atherosclerotic plaques detected in the coronary arteries; change in numbers of mixed plaques; change in numbers of calcified coronary plaques
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV+ on suppressive ART stable for > 1 year Age > 45 years Ability and willingness to provide written informed consent Exclusion Criteria: Uncontrolled chronic medical condition or cancer Acute illness within 2 weeks of entry Diagnosis of diabetes or impaired fasting glucose Chronic diarrhea Known hypersensitivity or contraindication to metformin use Hepatitis C co-infection Serum B12 level below the reference normal range as listed by the commercial laboratory (Diagnostic Laboratory Services) Pregnancy, or intent to become pregnant Any immunomodulator, HIV vaccine, any other vaccine, or investigational therapy within 30 days of study entry. Current or past history of coronary artery disease or congestive heart failure Resting heart rate > 100 beats/min Presence of conduction abnormalities or pathologic arrhythmia on EKG The following lab values: Hemoglobin < 9.0 g/dL; Absolute neutrophil count < 1000/μL; Platelet count < 50,000/μL; and AST (SGOT) and ALT (SGPT) > 5x ULN Calculated creatinine clearance (Cockcroft and Gault) < 60 ml/min Patients over 450 lbs History of iodine allergy or X-ray contrast allergy History of allergy to metoprolol Active or recent past history (within past 2 years) of illicit substance or alcohol use or abuse which, in the judgment of the Investigator, will interfere with the patient's ability to comply with the protocol requirements Patients in whom there are other reasons that the CAC/CTA procedure is contra-indicated or who are at higher risk of adverse events Patients, who, in the opinion of the Investigator, are unable to comply with the dosing schedule and protocol evaluation or for whom the study may not be advisable
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Hanks, RN
Phone
808 692-1336
Email
nhanks@hawaii.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Debra Ogata-Arakaki, RN
Phone
808 692-1332
Email
ogataara@hawaii.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia M Shikuma, MD
Organizational Affiliation
University of Hawaii
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawaii Center for AIDS
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilia Shikuma, MD
Phone
808-692-1328
Email
shikuma@hawaii.edu
First Name & Middle Initial & Last Name & Degree
Debra Ogata-Arakaki, RN
Phone
808 692-1332
Email
ogataara@hawaii.edu

12. IPD Sharing Statement

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Metformin for HIV Inflammation

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