Statement of Ltc. Robert R. Redfield

expansion because of the negative impact on other on-going. HIV
intervention modalities. It was agreed that DoD enrollment would
be limited to 300 but it was made clear that civilian sites would
be required to obtain the numbers of subjects required for a
statistically valid Phase II efficacy trial. In November 1991, the
Phase II protocol was reviewed at an FDA public combined advisor
meeting; at this meeting, both Wyeth-Ayerst and MicroGeneSys stated
that 500-600 patients would be required for sufficient sample size
and the use of surrogate endpoints. In addition, there was
consideration of a larger efficacy trial by the NIH in which case
there would be insufficient vaccine for both a DoD and a NIH trial.
Thus, a request to expand enrollment to civilian sites was made to
the MNCARR Retroviral Clinical Research and Tri-Service Operations
Committees. This meeting was held 23 January 1992. Issues relted
to DoD and non-DoD expansion were discussed in detail and at the
request of COL Burke a protocol addendum was submitted for TriService Human Use review. He also requested that we explore
involvement with NIH and it's related programs in order to maximize
federal cooperation in the vaccine therapy program. A number of
meetings were held to this end: Dr. Fauci and staff - 13 November
and 18 December 1991, the Aids Clinical Trial Group (ATCG) x 27
February 1992, Dr. Hoth and Community Programs for Clinical
Research on AIDS (CPCRA) staff and potential CPCRA sites per NIH's
recommendation - 17 June 1992. A gpl60 Phase II investigators
meeting was held in San Antonio 8-9 April 1992. Even though the
decision for expansion of the study had been decided at the June
1991 investigators meeting, the issue was reviewed and concurrence
obtained. In the meantime, the NIH had decided against ACTG
participation so the trial sponsor representative pursued
developing a network of non-NIH civilian sites for protocol
execution. Over 30 potential sites were reviewed by Wyeth Ayerst
and 10 were selected for evaluation. Following selection of two
civilian sites, we were called " NIH to determine our interest
in a CPCRA mechanism and a meeting with the NIH, CPCRA, Wyeth
Ayerst and us was held. Subsequently, investigator meetings at
both CPCRA and non-NIH civilian sites were conducted by Wyeth
Ayerst during site visits and based on their review, enrollment
sites were selected. On 25 June 1992 I sent a memorandum to COL
Burke with attached draft correspondence to the Associate Director
of CPCRA with reference to site selections and to the non-NIH
sponsored selected sites and requested his input earliest so that
the letters could be forwarded. His response to me was surprising;
She listed a number of issues to be fully addressed in wri'ng
before he could approve the expansion. I responded with the
requested details on 5 July 1992.

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