Impact of Metformin on Immuno-virologic Parameters in HIV
A 72 Week, Randomized, Open-label vs Observation Study to Assess the Potential Immuno-virologic Benefit of Metformin in HIV-infected Individuals Receiving Antiretroviral Therapy
Who can join
Ages 40 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
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 weeks in CD4 T cell negative checkpoint receptors (PD-1 and TIGIT). As secondary objectives the study will look at 72 week change in other immuno-virologic parameters (CD8 T cell negative checkpoint receptors, plasma indoleamine 2,3-dioxygenase (IDO) levels and CD4 T cell and monocyte intracellular HIV DNA and HIV RNA. The study will also explore the 72 week impact of metformin on change in carotid intima-media thickness (cIMT) as a surrogate marker of atherosclerosis, on neuropsychological (NP) performance, strength, and change in body composition.
What is being tested
- Metformin (drug)
Sponsor: University of Hawaii · Participants: 38 · Started: Feb 1, 2019
Contact the study team
- Cecilia M Shikuma, MD · Phone: 808 692-1328
- Debra Ogata-Arakaki, RN · Phone: 808 692-1332
Official record on ClinicalTrials.gov — NCT04500678
Locations in the U.S.
| Hawaii | John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.