Status:
UNKNOWN
Impact of Metformin on Immuno-virologic Parameters in HIV
Lead Sponsor:
University of Hawaii
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV/AIDS
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
Brief Summary
Non-diabetic, aviremic HIV-infected individuals on antiretroviral therapy (ART) will be randomized to metformin therapy or to observation for 72 weeks. Primary objective is to assess change over 72 we...
Eligibility Criteria
Inclusion
- HIV+
- On suppressive ART stable for \> 1 year
- Plasma HIV RNA \< 50 copies/mL within 3 months of entry, with no HIV RNA \> 200 copies/mL within the past 6 months prior to entry
- Age \>40 years
- Ability and willingness to provide written informed consent
Exclusion
- Uncontrolled chronic medical condition or cancer
- Acute illness within 2 weeks of entry
- Diagnosis of diabetes by history, fasting blood glucose \>126, or by HgbA1c \> 6.5
- Chronic, uncontrolled diarrhea
- Known hypersensitivity or contraindication to metformin use
- Current presence of hepatitis C including currently on or intent to start therapy for hepatitis C within the 48 week duration of study.
- Serum B12 level below the reference normal range as listed by the commercial lab utilized for this study (Diagnostic Laboratory Services)
- Pregnancy, or intent to become pregnant or nursing an infant
- Any immunomodulator, HIV vaccine, any other vaccine, or investigational therapy within 30 days of study entry.
- Current uncontrolled coronary artery disease or NYHA Class 3 or 4 congestive heart failure
- History of liver cirrhosis
- Current use of zidovudine, stavudine or didanosine
- The following lab values
- Hemoglobin \< 9.0 g/dL
- Absolute neutrophil count \< 1000/μL
- Platelet count \< 50,000/μL
- AST (SGOT) and ALT (SGPT) \> 5x upper limit of normal (ULN)
- Calculated creatinine clearance (Cockcroft and Gault) \< 50 ml/min
- 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, 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04500678
Start Date
February 1 2019
End Date
December 31 2022
Last Update
August 5 2020
Active Locations (1)
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1
John A. Burns School of Medicine, University of Hawaii - Manoa
Honolulu, Hawaii, United States, 96813