Recruiting
Phase 2

Metformin

Sponsor:

University of Hawaii

Code:

NCT02383563

Conditions

HIV

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

metformin extended release

Study Details

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.

Conditions

HIV

Coronary Artery Disease

Study ID

NCT02383563

Start date

Feb, 2015

Status verified date

Mar, 2015

Completion date

Feb, 2016

Anticipated

Primary completion date

Feb, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Metformin Treatment Arm

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

no intervention: Observational Arm

Observation only

Interventions

metformin extended release

Primary outcome measure

  • Coronary plaques by CT angiography [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Nancy Hanks, RN

808 692-1336nhanks@hawaii.edu

Debra Ogata-Arakaki, RN

808 692-1332ogataara@hawaii.edu

Locations

Hawaii Center for AIDS

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Cecilia Shikuma, MD

808-692-1328shikuma@hawaii.edu

Debra Ogata-Arakaki, RN

808 692-1332ogataara@hawaii.edu

More Information

Sponsor

University of Hawaii

Last update posted

Mar 9, 2015

Last verified

Mar, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Hawaii on 2015-03-09.