Metformin for HIV Inflammation
Open-Label, Randomized, 24-Week Pilot Study of Metformin vs Observation for Persistent Immune Activation in Chronic HIV Infection
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv
Started Feb 2015
Shorter than P25 for phase_2 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 9, 2015
CompletedFirst Posted
Study publicly available on registry
March 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 9, 2015
March 1, 2015
1 year
February 9, 2015
March 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Coronary plaques by CT angiography
change in total numbers of atherosclerotic plaques detected in the coronary arteries
24 weeks
Secondary Outcomes (3)
Monocyte subsets by multiparametric flow cytometry
24 weeks
Monocyte secretory function by intracellular cytokine staining release assay
24 weeks
Sub-types of coronary plaques by CT angiography
24 weeks
Study Arms (2)
Metformin Treatment Arm
ACTIVE COMPARATOR500 mg metformin Extended Release tablets - one tablet daily increased at 4 weeks to 2 tablets (1000 mg) daily.
Observational Arm
NO INTERVENTIONObservation only
Interventions
Eligibility Criteria
You may qualify if:
- HIV+
- on suppressive ART stable for \> 1 year
- Age \> 45 years
- Ability and willingness to provide written informed consent
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hawaii Center for AIDS
Honolulu, Hawaii, 96813, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cecilia M Shikuma, MD
University of Hawaii
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2015
First Posted
March 9, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 9, 2015
Record last verified: 2015-03