Transcript PROTOCOL TEAM

PROTOCOL TEAM
C Naidoo, S Emery, L Jacobs, R
Kennedy, N Stubbs, M Marumo, M
Polis, M Gezmu, D Follmann, J
Tavel, Z Makatini, J Msimang
Task 1: Report –
Accomplishments over past
year
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Completion of Phidisa I protocol.
Submitted to SANDF and NIAID IRBs
September 2003. Final approval
January 2004.
Completion of Phidisa II protocol.
Submitted to SANDF and NIAID IRBs
October 2003. Final approval January
2004.
Accomplishments over
past year (2)
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Tasked to develop a study to answer the
question of whether early administration of
ART would improve rates of survival and
disease progression – July 2003. – Group 1
Tasked to evaluate the benefit of a
nutritional supplement on HIV progression –
July 2003. Group 2
Accomplishments over
past year (3)
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Early ART Group bi-monthly tele –
conferences since Feb 04, and at July a
comprehensive draft protocol, CRF and
MOOP was made available for the EC
Nutrition group faced some administrative
and logistic challenges Despite this, a
working document was timeously made
available.
Task 2: Outcomes/Goals
for 2004/5
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Early intervention protocol and nutritional protocol
were integrated and completed by the Protocol
Operational Team.
Draft ready to be sent to other Operational Teams
and EC for comments and resource evaluation.
Approval of Phidisa III internally is required with
subsequent submission to the SANDF and NIAID
IRBs – October 2004.
Approval by IRBs – January 2005.
Initial implementation in February 2005, with full
implementation at all 6 Phidisa sites by July 2005.
Task 3: Identify Resources
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Budget not required except for the
need to conduct teleconferences
Goals:
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Comments from all other working
groups within 6 weeks of their receipt.
Comments to S Emery and C Naidoo, J
Tavel and Z Makatini
Task 4: Review
composition of team (1)
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In the absence of clearly defined goals
and future role of the team, the status
quo remains appropriate for the time
being.
Task 4: Review
composition of team (2)
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Composition of protocol teams for the
ongoing management of the different
protocols is required. We would
recommend that these teams should
be composed of protocol PIs as well as
representatives from the Data
Management, Pharmacy, Training and
Regulatory Sections of the DMCOC.
New research ideas
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Assess bioequivalence of FDC generics
Determine consensus on retrospective
evaluation of HIV drug resistance
Task 5: Evaluate Needs for
Amendments to Phidisa I
and II
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For Phidisa II, an amendment was required
to replace the use of nevirapine by
lopinavir/ritonavir in pregnant women for
the duration of the pregnancy. Women will
resume nevirapine post partum.
Reviewed and approved in discussions with
Pharmacy and Site Development WGs
Recommendations for
2004/5
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Procedures need to be established regarding
protocol amendments, operational approval,
and publication policy
Processes and administrative procedures
require clarity and definition – authorization
procedures for data accession will be
required with the end goal of the writing
and submission of abstracts by January
2005, and, subsequently, manuscripts.