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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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PROTOCOL TEAM

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  1. 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

  2. Task 1: Report – Accomplishments over past year • 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.

  3. Accomplishments over past year (2) • 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

  4. Accomplishments over past year (3) • 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.

  5. Task 2: Outcomes/Goals for 2004/5 • 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.

  6. Task 3: Identify Resources • Budget not required except for the need to conduct teleconferences

  7. Goals: • Comments from all other working groups within 6 weeks of their receipt. • Comments to S Emery and C Naidoo, J Tavel and Z Makatini

  8. Task 4: Review composition of team (1) • In the absence of clearly defined goals and future role of the team, the status quo remains appropriate for the time being.

  9. Task 4: Review composition of team (2) • 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.

  10. New research ideas • Assess bioequivalence of FDC generics • Determine consensus on retrospective evaluation of HIV drug resistance

  11. Task 5: Evaluate Needs for Amendments to Phidisa I and II • 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

  12. Recommendations for 2004/5 • 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.

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