Recruiting
Phase 2
Phase 3

Metformin

Sponsor:

University of Hawaii

Code:

NCT04500678

Conditions

HIV/AIDS

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Metformin

Study Details

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 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.

Conditions

HIV/AIDS

Study ID

NCT04500678

Start date

Feb 1, 2019

Status verified date

Aug, 2020

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Feb 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

38 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Metformin

Metformin 500 mg Extended Release (ER) qd increasing to 1000 mg ER qd at week 4 and continued to week 48.

no intervention: Observation

Observed without metformin

Interventions

Metformin

Metformin 500 mg Extended Release (ER) qd increasing to 1000 mg ER qd at week 4 and continued to week 48.

Primary outcome measure

  • CD4 T cell PD1+TIGIT+ [ Time Frame: Entry to week 72 ]

Central Contacts and Locations

Central contacts

Cecilia M Shikuma, MD

808 692-1328shikuma@hawaii.edu

Debra Ogata-Arakaki, RN

808 692-1332ogataara@hawaii.edu

Locations

John A. Burns School of Medicine, University of Hawaii - Manoa

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Cecilia Shikuma, MD

808-692-1328shikuma@hawaii.edu

Debra Ogata-Arakaki, RN

808 692-1332ogataara@hawaii.edu

More Information

Sponsor

University of Hawaii

Last update posted

Aug 5, 2020

Last verified

Aug, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Hawaii on 2020-08-05.