HIVPhase 2NCT02383563
Metformin for HIV Inflammation
A Phase 2 study testing metformin extended release in people with HIV and Coronary Artery Disease, run by University of Hawaii at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- HIV, Coronary Artery Disease
- What is being tested?
- metformin extended release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV+
- on suppressive ART stable for > 1 year
- Age > 45 years
- Ability and willingness to provide written informed consent
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hawaii Center for AIDS
Honolulu, Hawaii, 96813
Cecilia Shikuma, MD, 808-692-1328, shikuma@hawaii.edu
Debra Ogata-Arakaki, RN, 808 692-1332, ogataara@hawaii.edu
About this study
Official title: 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.
- Conditions
- HIV, Coronary Artery Disease
- Being tested
- metformin extended release
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metformin extended releaseDrug
| Study group | Role | What they receive |
|---|---|---|
| Metformin Treatment Arm | Active comparator | 500 mg metformin Extended Release tablets - one tablet daily increased at 4 weeks to 2 tablets (1000 mg) daily. Receives: Drug: metformin extended release |
| Observational Arm | No intervention | Observation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary plaques by CT angiography
change in total numbers of atherosclerotic plaques detected in the coronary arteries
Measured: 24 weeks
Secondary outcomes (3)
Monocyte subsets by multiparametric flow cytometry
change in numbers (cells/microliter of blood) of each monocyte subset (classical, intermediate, non-classical and transitional subsets)
Measured: 24 weeks
Monocyte secretory function by intracellular cytokine staining release assay
Change in percent of monocytes secreting cytokine TNFalpha, percent secreting cytokine IL-6 and percent secreting cytokine IL-1beta
Measured: 24 weeks
Sub-types of coronary plaques by CT angiography
Change in numbers of non-calcified atherosclerotic plaques detected in the coronary arteries; change in numbers of mixed plaques; change in numbers of calcified coronary plaques
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Cecilia M Shikuma, MD, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383563
- Sponsor's protocol ID
- H028
- Other IDs
- P30GM103341
- Status last verified
- Mar 2015
- First submitted
- 9 Feb 2015
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, 24-Week Pilot Study of Metformin vs Observation for Persistent Immune Activation in Chronic HIV Infection
- ClinicalTrials.gov ID
- NCT02383563
- Acronym / sponsor ID
- H028
- Conditions
- HIV, Coronary Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin Treatment Arm | Active comparator | Drug: metformin extended release500 mg metformin Extended Release tablets - one tablet daily increased at 4 weeks to 2 tablets (1000 mg) daily. |
| Observational Arm | No intervention | –Observation only |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV+
- on suppressive ART stable for > 1 year
- Age > 45 years
- Ability and willingness to provide written informed consent
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metformin extended release | Drug | Metformin Treatment Arm |
Primary outcome
Coronary plaques by CT angiography
Time frame: 24 weeks
change in total numbers of atherosclerotic plaques detected in the coronary arteries
3 secondary outcomes
Monocyte subsets by multiparametric flow cytometry
Time frame: 24 weeks
Monocyte secretory function by intracellular cytokine staining release assay
Time frame: 24 weeks
Sub-types of coronary plaques by CT angiography
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia M Shikuma, MD principal investigator
University of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing metformin extended release in people with HIV and Coronary Artery Disease, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy Hanks, RN (808 692-1336, nhanks@hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary plaques by CT angiography (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015; AzTrials last refreshed its copy on 29 Oct 2026.