Metformin for HIV Inflammation

University of Hawaii

Status and phase

Unknown

Phase 2

Conditions

Coronary Artery Disease

HIV

Treatments

Drug: metformin extended release

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02383563

P30GM103341 (U.S. NIH Grant/Contract)

H028

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No 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