Metformin for HIV Inflammation

• Status: Unknown status
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Hawaii
• Collaborator: National Institute of General Medical Sciences (NIGMS)
• Treatments: Metformin

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