Clinical trial NCT02383563: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HIV
Coronary Artery Disease
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2015-03-09
Enrollment: 12
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Coronary plaques by CT angiography
timeFrame: 24 weeks
Secondary outcomes:
measure: Monocyte subsets by multiparametric flow cytometry
timeFrame: 24 weeks
measure: Monocyte secretory function by intracellular cytokine staining release assay
timeFrame: 24 weeks
measure: Sub-types of coronary plaques by CT angiography
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Hawaii Center for AIDS
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Cecilia M Shikuma, MD
role: PRINCIPAL_INVESTIGATOR
References: