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Clinical Research Laboratory at the University of Maryland School of Medicine 

The Zhao Clinical Research Laboratory at the University of Maryland School of Medicine is certified by the Clinical Laboratory Improvement Amendments (CLIA ID#: 21D1106504) and the Maryland Department of Health and Mental Hygiene (Permit Number 1564).

Location: Room 716, Medical Science Teching Facility (MSTF), University of Maryland School of Medicine, 10 South Pine Street, Baltimore, MD 21201

For clinical research and trial information, please contact Dr. Richard Y. Zhao or call 410-706-6300.                         

 

The ZhaoLab participates in various clinical trials and related clinical research activities including, 

2010-present  (PI: R. Horenstein): Nation-wide clinical trials on “Randomized trial of genotype-guided dosing of Warfarin therapy” (NLHBI/NIH)

2010-2012 “CYP2C19 Genotyping and Plavix Therapy” (Nanosphere Inc.)

2010-2011 “Development of Rapid Point-of-Care Tests for Women's Health” (NIAID/Cellex)

2010-present “Clinical Study on Processing Cancer Tissues” (Maryland Industrial Partnership Program/BioQuick)

2010-2013 “Rapid Screen for Blood-Borne Pathogens” (DOD/MesoScale)

2009-2010 “A Rapid POC Flu Test”. (Maryland Industrial Partnership Program/Cellex)

2009-2010  “A Reproducibility Study of a Microelisa HIV-1 Detection Method” (Avoiq)  

2008-2009   “A Novel Bacterial Vaginosis Test”. (Maryland Industrial Partnership Program/Cellex)  

2008-2009   “Emergence of HIV-1 Non-B Sub-types and Its Impact on Emergence of Drug Resistance, Viral Load Measurement and Response to Therapies”. (Abbott Molecular)”;  

2004-2008    “Validating Supplemental Testing to Confirm Preliminary Positive Rapid HIV Tests Study Protocol MDC-03-03”, (CDC);

2004-2007   “Quality Control/Quality Assurance Laboratory for the Early Detection Research Network’s (EDRN) validation study of Microsatellite in DNA of urine sediment as a marker for recurrence of bladder cancer” (NCI/NIH);

 

Zhaolab  has also participated in the following national and international HIV/AIDS trials, task forces and committees:

Pediatric Virology Committee, National AIDS Clinical Trials Groups (PACTG)  

Virological Sub-study of PACTG 345: Yuqi Zhao, Ph.D., Principal Investigator

PACTG 1012: Yuqi Zhao, Ph.D. Protocol Virologist

PACTG 1038: Yuqi Zhao, Ph.D. Protocol Virologist

AACTG Genotypic Resistance/Sequencing Swat Team

In situ Drug Resistance Screening Swat Team

Pediatric HIV-1 Drug Resistance Working Group

Multicenter Evaluation on HIV-1 Genotyping and Sensitivity in Detecting Minor Drug Resistant HIV-1

HIV-1 Proviral DNA Quantitation Group  

ACTG Junior Investigator, Ad Hoc Steering Committee 

 

 

 

 

 

 

Multicenter Evaluation on HIV-1 Genotyping and Sensitivity in Detecting Minor Drug Resistant HIV-1 (2002-2003) 

Roster:

Elias Halvas
Grace Aldrovandi
Karin Metzner
Valerie Boltz
dwight V. Nissley
Rainer Ziermann
Lisa M. Frenkel
Marek Nowicki
Mary
Kearney  
Peter Balfe  
Andrea Kovacs    
Don Brambilla
James W. Bremer  
Ingrid Beck  
John Mellors
Yuqi Zhao

Publications:

Halvas, E., G. Advovand, P. Balfe, I. Beck, V. Boltz, L. Frenkel, A. Kovacs, K. Metzner, D. Nissley, M. Nowicki, R. Ziermann, Y. Zhao, C. Jennings, J. Bremer, D. Brambilla and J. Mellors. 2003. Blinded, multicenter comparison of the sensitivity of different technologies to detect and quantify a minor drug-resistant HIV-1 variant. The tenth Conference on Retroviruses and Opportunistic Infections, Boston.

 

 

 

 

 

Pediatric Virology Committee (1999-2003)

Goal and Objectives:

The Virology Committee provides scientific expertise in identifying important virologic issues and solving problems through the design of laboratory protocols, as well as (when necessary) clinical protocols. The Virology Committee is essential to the RACs in helping to answer questions relating to HIV pathogenesis in HIV-infected pregnant women, children, and adolescents. It also oversees the Virology core laboratories and assures, through a quality-control program and prioritization of activities, that they function to serve the needs of the PACTG.

The following are the specific aims of the Virology Scientific Committee:                                                                                                                     

Specific Aim 1. To provide and administrate a network of laboratories capable of supplying virologic support to clinical trials protocols, and data that will contribute to a better understanding of the pathogenesis of HIV infection among pregnant women, children, and adolescents.

Specific Aim 2. To provide the capacity for developing and applying new virologic methods and altering existing methods to further the aims of the pediatric scientific agenda.

Specific Aim 3. To provide virologic support and leadership to the RACs and expert virologic advice for the design and execution of clinical trials.

Roster:

Paul Palumbo, MD, Chair, UMDNJ/New Jersey Medical School
Grace Aldrovandi, MD, Vice-Chair, Univ. of Alabama at Birmingham
James W. Bremer, PhD, Rush-Presbyterian/St. Lukes, Retrovirology Laboratory
Yvonne J. Bryson, MD, UCLA School of Medicine
Evan Caten, Laboratory Project Coordinator, Statistical and Data Analysis Center
Robert W. Coombs, MD, PhD, University of Washington
Susan A. Fiscus, PhD, University of North Carolina School of Medicine
Lisa M. Frenkel, MD, Children's Hospital and Medical Center, Seattle, WA 98105-
Maureen Goodenow, MD, University of Florida
J. Brooks Jackson, MD, Johns Hopkins Univ.
Shirley Jankelevich, MD, NIH, NIAID, DAIDS, TRP, PMB
Jonathan Kagan, PhD, NIH, NIAID, DAIDS, TRP
Janet L Lathey, PhD, Univ. of California at San Diego
William A. Meyer, III, PhD, Quest Diagnostics Incorporated
Beatrice Montelongo, Whittier, CA 90606
Jack Moye, Jr., MD, National Institute of Child Health & Human Development, NIH
Carol Mundy, University of California at San Diego
Deborah Persaud, MD, Johns Hopkins University
Jane Pitt, MD, Columbia University College of Phys. & Surgeons
Patricia Reichelderfer, PhD, NICHD, NIH
Holly Schneider, MS, AACTG/PACTG Operations Center
Walter A. Scott, PhD, University of Miami School of Medicine
Suzanne Siminski, MS, MBA, Frontier Science & Technology Research Foundation
Stephen A. Spector, MD, University of California, San Diego
John L. Sullivan, MD, Univ. of Massachusetts Med. Sch.
Lee-Jen Wei, PhD, SDAC/Harvard School of Public Health
Yuqi Zhao, PhD, Chicago Children's Memorial Hospital/Northwestern University Feinberg School of Medicine
 
 
 

Virologic Sub-study of PACTG345 

Protocol Number: PACTG 345

 Protocol Title: A Phase I/II Study of Ritonavir Therapy in HIV-1 Infected Infants and Children Abst. 467.

 

 

 

 

 

 

 

 

 

PACTG1012 

A Phase I Pharmacokinetic Study of Once Versus Twice Daily Dosing With Zidovudine

Sponsored by: The National Institute of Allergy and Infectious Diseases ; Pharmaceutical Support Provided by: Glaxo Wellcome, Inc.

Roster

Protocol Chair
Patricia M. Flynn, MD
St. Jude Children's Research Hospital
 
Protocol Vice Chairs
John Rodman, PharmD
St. Jude Children's Research Hospital
 
NICHD Medical Officer
Audrey Rogers, PhD, MPH
Pediatric, Adolescent, and Maternal AIDS Branch
NICHD, CRMC
 
Clinical Trials Specialist
Victoria Hadhazy, MA
PACTG Operations Center
 
Protocol Statistician
YouGan Wang, PhD
SDAC/Harvard School of Public Health
 
Protocol Data Manager
Pamela Bouquin, BA
Frontier Science & Technology
Research Foundation/P-DMC
 
Field Representative
Christine Owen, RN, BSN
Baylor/Texas Children's Hospital
 
Protocol Pharmacist
Lynette Purdue, PharmD
Pharmaceutical Affairs Branch
NIH, NIAID, DAIDS, TRP
 
Protocol Virologist
Yuqi Zhao, PhD
Chicago Children's Memorial Hospital
Northwestern University Medical School
 
Protocol Pharmacologist
John Rodman, PharmD
St. Jude Children's Research Hospital
 
Adolescent Representative
Margaret Silio, MD
 
Laboratory Technologists
David Shugarts, MA
University of Colorado Health Sciences Center
Brian Robbins, PhD
St. Jude Children’s Research Hospital
 
Pharmaceutical Company Representative
Barbara A. Lane , RN, MSN, CPNP
Glaxo-Wellcome, Inc.
 
CCG Representative
Margie Rogillio
Tulane University
 
Investigators
Wayne Mathew Dankner, MD
University of California at San Diego Medical Center
Alejandro Dorenbaum, MD
University of San Francisco

Objectives:

Primary

1. Compare the steady state predose amounts of ZDV-triphosphate (TP) and 3TC-TP in is administered once versus twice daily.

2. Describe the kinetics of phosphorylation of ZDV and 3TC mono-, di-, and triphosphates in

Secondary

1. Determine adherence using the PACTG Adherence Modules.

2. Monitor plasma HIV-1 RNA viral load changes on once versus twice daily dosing regimens with Combivir.

3. Provide an estimate of the variability in the expression of MRP4 protein and examine

 

 

 

PACTG1038

ABILITY OF High DOSE  LOPINAVIR/RITONAVIR (KALETRATM)  TO ACHIEVE INHIBITORY QUOTIENT ≥15 IN PEDIATRIC SUBJECTS PREVIOUSLY TREATED WITH PROTEASE INHIBITORS

A Multicenter Center Trial of the Pediatric AIDS Clinical Trials Group

Sponsored by: The National Institute of Allergy and Infectious Diseases

Pharmaceutical Support Provided by: Abbott Laboratories

Primary Objectives:  

1.      To measure the proportion of PI-experienced subjects achieving the target IQ on Kaletra alone.

2.     To determine the safety and tolerability of KaletraTM given in higher doses than currently recommended by its manufacturer's information package.

Secondary Objectives:  

1.      To correlate viral genotypes (drug resistance profiles of RT and protease genes) with potential failure in achieving IQ>15, before and after KaletraTM treatment.

2.      To compare HIV-1 genotyping with phenotyping assays in their ability to predict susceptibility of the subjects viral isolate to drug treatment.

3.      To estimate pharmacokinetic parameters for KaletraTM in protease inhibitor pre-treated HIV-infected children and adolescents receiving doses high enough to achieve concentrations sufficient to provide activity relative to an estimated EC50.

4.      To assess relationship between subject characteristics including age, body size, and gender and KaletraTM pharmacokinetic parameters.

5.      To determine variability in systemic exposure over the duration of therapy by measuring pre-dose KaletraTM concentrations at regular intervals.

6.      To evaluate genotypes for CYP3A and pGP as contributing sources of variability to KaletraTM metabolism.

7.      To determine the free concentrations of lopinavir with concurrent measurements of AAGP and serum albumin.

Team Roster  

Protocol Chair
Peter L. Havens, M.D.
Medical College of Wisconsin
Children's Hospital of Wisconsin
 
Protocol Vice Chairs
Ellen G. Chadwick, M.D.
Chicago Children's Memorial Hospital
 
Protocol Vice Chairs (Cont.)
Stephen I. Pelton, M.D.
Boston University School of Medicine
Boston Medical Center
 
Ram Yogev, M.D.
Chicago Children's Memorial Hospital
 
Medical Officer
Shirley Jankelevich, M.D.
Pediatric Medicine Branch
NIH, NIAID, DAIDS, TRP
 
NICHD Medical Officer
Leslie Serchuck, M.D.
Pediatric, Adolescent, and Maternal
AIDS Branch
NIH, NICHD, CRMC
 
Clinical Trials Specialist
Elizabeth Hollomon R.N., B.S.N., C.C.M.
Pediatric ACTG Operations Center
 
Protocol Statisticians
Terence Fenton, Ed.D.
Senior Statistician
Section Head, SDAC/FSTRF,
 
Christine Powell
Protocol Statistician
Center for Biostatistics in AIDS Research
Harvard School of Public Health
 
Protocol Data Manager
Barbara Heckman, B.S.
Frontier Science and Technology Research Foundation
 
Field Representative
Debbie Fonken-Cloutier, R.N., B.S.N.
Research Coordinator
Children's Memorial Hospital
 
Protocol Pharmacist
Elaine Ferguson, R.Ph., M.S.
Pharmaceutical Affairs Branch
NIH, NIAID, DAIDS
 
Protocol Virologist
Yuqi Zhao, Ph.D.
Chicago Children's Memorial Hospital
 
Protocol Immunologists
William Borkowsky, M.D.
NY Univ. Med. Ctr./Bellevue Hospital
 
Protocol Pharmacologist
John H. Rodman, Pharm.D.
St. Jude Children's Research Hospital
 
Laboratory Technologist
Diane Holland, M.Phil.
University of California
 
Non-PACTG Laboratory Representative
Nicholas Hellmann, M.D.
VirLogic, Inc.
 
Pharmaceutical Company Representative(s)
Richard J. Bertz, Ph.D.
Abbott Laboratories
 
Randall L. Tressler, M.D.
Abbott Laboratories
 
 
 
 

AACTG Genotypic Resistance/Sequencing Swat Team Members (1995-1998)

Lisa DeMeter, MD, (Rochester University), Chair
Max Arens, MD (Washington University)
Richard D'Aquila, MD (Harvard University)
Alejo Erice, MD (University of Minnesota)
Joe Fitzgibbon
Tony Japour, MD (Harvard University)
Victoria Johnson, MD (University of Alabama)
Dan Kuritzkes, MD (MIT)
Doug Mayers, MD (Walter Reed Army Institute)
Suraiya Rasheed, MD (USC)
Pat Reichelderfer, PhD (NIH) Originator
Doug Richman, MD (UCSD)
Bob Shafer, MD, (Stanford University)
Owen Weislow, PhD (SRA Technologies Inc.)
Mark WintersYuqi Zhao, PhD, (Northwestern University)

Publications
Demeter, LM, E Fisher, R D'Aquila, O Weislow, A Erice, J Eitzgibbon, R Shafer, D Richman, T Howard, Y Zhao, D Huang, D Mayers, S Sylvester, M Arens, K Sannerud, S Rasheed, V Johnson, D Kuritzkes, P Reichelderfer and A Japour. 1998. Interlaboratory Concordance of DNA Sequence Analysis to Detect Drug Resistance Mutations in HIV-1 Reverse Transcriptase. Journal of Virologic Methods. 75:93-104.

DeMeter, L, D Huang, R Shafer, T Howard, R Schuurman, C White, D Gallahan, O Weislow, R Colgrove, E Fisher, M Arens, Y Zhao, S Rasheed, P Reichelderfer and L Johnston-Dow. 1997. Development of a consensus sequencing protocol to detect drug resistance mutations in HIV-1 protease and reverse transcriptase. 1997 Conference of Infectious Diseases Society of America (IDSA), San Francisco, CA

.DeMeter, L, K. Sannerud, D. Mayers, J. Fitzgibbon, S. Sylvester, M. Arens, E. Fisher, R. Shafer, Y. Zhao, D. Huang, P. Reichelderfer, V. Johnson, D. Richman, S. Rasheed, D. Kuritzkes , A. Japour, and the ACTG Genotypic Resistance Working Group 1995. Interlaboratory concordance of DNA sequence analysis of the HIV?1 reverse transcriptase (RT). Abst. in 35th ICAAC, San Francisco, CA I284, p256.

DeMeter, L, K Sannerud, D Mayers, J Fitzgibbon, S Sylvester, M Arens, E Fisher, R Shafer, Y Zhao, D Huang, P Reichelderfer, V Johnson, D Richman, S Rasheed, D Kuritzkes, A Japour, and the ACTG Genotypic Resistance Working Group 1995. Interlaboratory concordance of DNA sequence analysis of the HIV?1 reverse transcriptase (RT). 20th ACTG Meeting, Washington D.C., #12

 

 

 

 

 

In situ Drug Resistance Screening Swat Team Members (1996)

Vinayaka Prasad, MD (Albert Einstein College of Medicine), Chair
Charles Boucher, MD (University of Amsterdam)
Vera Byrnes (Merck Co.)
Pam Chatis (DuPont Col)
Lisa DeMeter, MD (Rochester University)
Lisa Frenkel, MD (University of Washington, Seattle)
Diana Huang, PhD (Rush Medical College, Chicago)
Tony Japour, MD (Beth Israel Hospital)
Israel Lowy, MD (Columbia University)
Doug Mayers, MD (Walter Reed Army Institute)
Yaffa Mizrachi, MD (Albert Einstein College of Medicine)
Suraiya Rasheed, MD (USC)
Robert Shafer, MD (Stanford University)
Ranga Srinivas, MD (St. Jude Children's Hospital)
Kathleen Stellrecht, MD (Albany Medical College)
Yuqi Zhao, PhD (Northwestern University)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACTG Junior Investigator, Ad Hoc Steering Committee (1995-1998)

Judith Currier, MD (USC)
Carl Fichtenbaum, MD (Washington University, St. Louis)
Trip Gulick, MD (NYU)Stephen Hausrath, MD (Harvard University)
Tony Japour, MD (Harvard University)
Patricia Meehen, PhD (SDAC/FS&T Research Foundation, Inc.)
Stacy Bradley (NIH ACTG Operation Office)
Pat Reichelderfer PhD (NIH DAIDS)
Camlin Tierney, PhD (SDAC/Harvard University)
Yuqi Zhao, PhD (Northwestern University)

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pediatric HIV-1 Drug Resistance Working Group (1999 - present)

Goal and Objectives:

To develop and validate consensus protocols for accurate quantification of HIV-1 proviral DNA.

Roster:

Robert Coombs, Chair
John Bartlett
Jim Bremer
Yvonne Bryson
David Chernoff
Ruth Dickover
Pamela Esterling
Jocqueline Gills
Scott Hammer
Shirley Kwok
HJ Lin
Cheryl Michels
Marek Nowicki
Ven Nataranjan
Paul Palumbo
Greg Petterson
Suraiya Rasheed
Pat Reichelderfer
Doug Richman
Walter Scott
Sue Sepelak
Robert Siliciano
Stephen Spector
Brian Staes
John Sullivan
Maryanne Vahey
Sarah Williams
Mark Winters
Joseph Wong
Belinda Yen-Lieberman
Yuqi Zhao

Publications:

Yu. M., W. Kabat, J. Wang, T. Hung, R. Yogev, and Y. Zhao. 2000. Rapid detection of drug resistant HIV-1 to reverse transcriptase and protease inhibitors in HIV-infected patients receiving highly active antiretroviral therapies. Chinese Journal of Clinical and Experimental Virology 14(4):325-329. 

 

HIV-1 Proviral DNA Quantification Working Group (1999 - present)

Goals and Objectives:

To validate a HIV-1 genotyping assay and implementation in pediatric clinical trials.

Roster:

Paul Palumbo, Chair
Yvonne Bryson, MD, UCLA
Lisa Frankel, MD, Univ., of Washington, Settale
Susan A. Fiscus, PhD, Univ. of North Carolina
Grace Aldrovandi, MD, UAB
Diana Huang, PhD, Rush Univ., Chicago
Jane Pitt, MD, Columbia University
Walter Scott, PhD, Univ. of Florida
Yuqi Zhao, PhD, Northwestern Univ. Med School

Publications:

Zhao, Y., Yu, M., Y. Miller, M. Chen, E. Bremer, W. Kabat, and R. Yogev. 2002. Quantification of Human Immunodeficiency Virus Type 1 Proviral DNA by Using TaqMan technology. Journal of Clinical Microbiology. 40(2):675-678.

 

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