Metformin for HIV Inflammation
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, HIV / AIDS |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 4/2/2016 |
| Start Date: | February 2015 |
| End Date: | February 2016 |
| Contact: | Nancy Hanks, RN |
| Email: | nhanks@hawaii.edu |
| Phone: | 808 692-1336 |
Open-Label, Randomized, 24-Week Pilot Study of Metformin vs Observation for Persistent Immune Activation in Chronic HIV Infection
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.
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.
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
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