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HIV
Prevention Trials Units
Network Leadership Scientific
Management
Network
Committees
CORE
Network Lab
SDMC
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Network Laboratory (NL)
Under the leadership of
Susan Eshleman of Johns Hopkins University, the NL is responsible for
collecting, testing and reporting results from biological samples;
assisting in the development and quality assurance assessment of local
laboratory capacity at the Clinical Trials Units (CTUs) participating in
HPTN clinical trials; and identifying and implementing state-of-the-art
assays and technologies to advance the scientific agenda of the Network.
Network Laboratory
Objectives
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Participate in management of the
HPTN and establishment of the HPTN Scientific Agenda.
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Provide laboratory-based
scientific leadership and consultation to the HPTN.
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Participate in HPTN protocol
development and review.
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Collaborate with other National
Institutes of Health (NIH)-sponsored HIV clinical trials networks to
harmonize laboratory methods and maximize the efficiency of protocol
development, implementation and analysis.
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Provide processing, storage and
retrieval guidelines for domestic and international HPTN trial specimens.
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Provide QA for specimen
processing, assay performance and specimen-related data transmission for
testing performed at CTU laboratories.
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Provide training and
infrastructure support in laboratory QA, assay performance and specimen
shipping procedures at CTU laboratories.
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Provide continued opportunities
for technology transfer, particularly to international HPTN laboratories.
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Perform novel and routine
immunologic, virologic, pharmacologic and other testing for HPTN protocols.
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Evaluate and validate new assays
for clinical trials of HIV prevention, with particular emphasis on assays
that can be used in HPTN trials.
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Coordinate procedures for
transmission of laboratory data to the HPTN SDMC
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Work with the Managing Partners
and Cross Network Committees to harmonize laboratory procedures across DAIDS-sponsored
networks.
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Develop QA/QC and training tools
and materials for use in domestic and international laboratories across
DAIDS-sponsored networks.
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Publish findings of assay
development/evaluation and pathogenesis-based studies.
CTU Laboratory
Expectations
CTU Laboratories are
expected to do the following:
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Routine safety laboratory assays including hematology and chemistry
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HIV
antibody testing
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CD4/CD8 cell counts
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HIV
RNA PCR testing (preferably Roche AMPLICOR version 1.5)
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have adequate monitored specimen storage equipment and backup
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Meet IATA regulations for shipment of specimens
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Adhere to good clinical laboratory practices in performance of assays for
HPTN trials
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Participate in proficiency testing panels and maintain adequate proficiency
in protocol related testing
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Use
the Laboratory Data Management System (LDMS) for specimen storage, tracking
and shipping
Quality Assurance Measurements
The Quality Assurance (QA)
staff at the Network Lab will measure the following parameters on an ongoing basis:
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Validation of assay
runs
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Retesting
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Turn Around Time (TAT)
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Proficiency Testing
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Integrity and security
of specimen repository
Network Laboratory News
|
New Shipping Label
Requirement
Effective January 1,
2007, all UN3373 labels
need to be changed to include "Biological Substance Category B" -
learn more
New online
CD4 Enumeration training
CD4
Enumeration E-Learning Course
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Network Laboratory
Resources
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Network Laboratory Staff &
Affiliates
Yaw Agyei
get info
Robert C. Bollinger
get info
Marcelo Cardona
get info
Karen Carroll
get info
William Clarke
get info
Tynia Conley
get info
Susan Eshleman
get info
Charlotte A. Gaydos
get info
Lisa Heid
get info
Craig Hendrix
get info
Danielle Heyl
get info
Sarah Hudleson
get info
LeTanya Johnson-Lewis
get info
Danielle Jones
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Lebah Lugalia
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Joseph Margolick
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Terry Parsons
get info
Estelle Piwowar-Manning
get info
Paul Richardson
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Theresa Shapiro
get info
Alexandra Valsamakis
get info
Michelle Xing
get info
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