Mark Holodniy

Professor of Medicine (Infectious Diseases)

Bio

Dr. Holodniy specializes in the treatment of infectious diseases with an expertise in the care of patients with viral infections. He maintains broad investigative programs in the field of infectious diseases, encompassing clinical trials, surveillance for emerging infections, and translational correlates. He is the Principal Investigator on numerous clinical trials. He is the Director of the Public Health National Program Office and Public Health Reference Laboratory for the Department of Veterans Affairs.

Academic Appointments

Professor - University Medical Line, Medicine - Infectious Diseases
Member, Bio-X

Administrative Appointments

Chairman, Administrative Panel on Biosafety (2017 - Present)
Co-Chairman, Administrative Panel on Biosafety (1995 - 2017)
Member, Medical School Faculty Senate (1999 - 2002)

Honors & Awards

Research and Development Award, AMSUS, The Society of Federal Health Professionals (2024)
Robert L. Jesse Clinical Innovation Award, Department of Veterans Affairs (2023)
Fellow, Infectious Disease Society of America (2005)
Fellow, Society for Healthcare Epidemiology of America (2005)
Divisional Award for Exceptional Contributions in Education in the Division of Infectious Disease, Department of Medicine (2004)
Infectious Diseases Teaching Award, Division of Infectious Diseases (2004)
HIV Program Clinical Excellence Award, Department of Veterans Affairs (2001)
Infectious Diseases Teaching Award, Division of Infectious Diseases (1997)
Fellow, American College of Physicians (1996)

Boards, Advisory Committees, Professional Organizations

Member, DHHS-Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Executive Council (2022 - Present)
Member, Infectious Diseases Society of America (IDSA) Diagnostics Committee (2017 - 2020)
Member, DHHS-Public Health Emergency Medical Countermeasures Enterprise Diagnostics Integrated Program Team. (2014 - 2018)
Editor-in-Chief, Diagnostic Microbiology and Infectious Disease (2013 - 2023)
Member, CDC-National Syndromic Surveillance Program Governance Board (2012 - 2018)
Associate Editor, International Journal of Infectious Diseases (2008 - 2013)

Professional Education

BS, Seattle University, Biology (1980)
MD, Northwestern University, Medicine (1985)

Patents

Merigan TC, Katzenstein DA, Holodniy M. "United States Patent 5,968,730 HIV PCR Directs Drug Use", Leland Stanford Junior University
Merigan TC, Katzenstein DA, Holodniy M. "United States Patent 6,503,705 Polymerase Chain Reactions for Monitoring Antiretroviral Therapy and Making Therapeutic Decisions in the Treatment of Acquired Immunodeficiency Syndrome", Leland Stanford Junior University
Merigan TC, Katzenstein DA, Holodniy M. "United States Patent 7,129,041 Polymerase chain reaction assays for monitoring antiviral therapy and making therapeutic decisions in the treatment of acquired immunodeficiency syndrome", Leland Stanford Junior University

Current Research and Scholarly Interests

My research program is currently focused in three areas: 1) Translational research (viral evolution and antiviral resistance prevalence and development), 2) Clinical trials (diagnostic assay/medical device, antimicrobials and immunomodulators), and 3) Health services research focusing on public health, infectious diseases and clinical outcomes.

Clinical Trials

Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir) Recruiting
More
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.
Lead Sponsor
Stanford Investigators
- Mark Holodniy
View full details
Adaptive COVID-19 Treatment Trial (ACTT) Not Recruiting
More
This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.

Stanford is currently not accepting patients for this trial. For more information, please contact NIH sponsored, 6504935000.
Lead Sponsor
Stanford Investigators
View full details
Optimal Treatment for Recurrent Clostridium Difficile Not Recruiting
More
The purpose of this study is to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile infection.

Stanford is currently not accepting patients for this trial. For more information, please contact Mark Holodniy, MD, 650-852-3408.
Lead Sponsor
Stanford Investigators
- Mark Holodniy
View full details
Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics Recruiting
More
The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in diabetic patients. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis in both diabetics and non-diabetics. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many Veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA.
Lead Sponsor
Stanford Investigators
- Mark Holodniy
View full details
Evaluation of Alternative Oseltamivir (Tamiflu) Dosing Strategies. Not Recruiting
More
Objective 1: Determine the safety and toxicity profile of Tamiflu administered in combination with probenecid in healthy adults.Objective 2: Determine the pharmacokinetic profile of Tamiflu and probenecid in healthy adults.

Stanford is currently not accepting patients for this trial. For more information, please contact SPECTRUM, .
Lead Sponsor
Stanford Investigators
- Mark Holodniy
View full details
Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection Not Recruiting
More
To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.

Stanford is currently not accepting patients for this trial. For more information, please contact Mark Holodniy, MD, 650-852-3408.
Lead Sponsor
Stanford Investigators
- Mark Holodniy
View full details
Methylphenidate Plus GWI-Nutrient Formula as a Treatment for Patients With Gulf War Illness Not Recruiting
More
The Gulf War Synergy Trial will evaluate the safety and efficacy of a currently available medication, methylphenidate (Ritalin®), combined with a GWI Nutrient Formula (K-PAX Synergy) to treat Gulf War Illness (GWI).

Stanford is currently not accepting patients for this trial. For more information, please contact Mark Holodniy, 650-493-5000.
Lead Sponsor
Stanford Investigators
- Mark Holodniy
View full details
ACTIV-3: Therapeutics for Inpatients With COVID-19 Not Recruiting
More
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

Stanford is currently not accepting patients for this trial. For more information, please contact SPECTRUM, 6507245282.
Lead Sponsor
Stanford Investigators
View full details
Clostridium Difficile Vaccine Efficacy Trial Not Recruiting
More
The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.

Stanford is currently not accepting patients for this trial. For more information, please contact Mark Holodniy, 650-493-5000.
Lead Sponsor
Stanford Investigators
- Mark Holodniy
View full details

2023-24 Courses

Independent Studies
- Directed Reading in Medicine
  MED 299 (Aut, Win, Spr, Sum)
- Early Clinical Experience in Medicine
  MED 280 (Aut, Win, Spr, Sum)
- Graduate Research
  MED 399 (Aut, Win, Spr, Sum)
- Medical Scholars Research
  MED 370 (Aut, Win, Spr, Sum)
- Undergraduate Research
  MED 199 (Aut, Win, Spr, Sum)

Graduate and Fellowship Programs

All Publications

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