[Memorandum to Acting Deputy Director for Intramural Research, NIH from F. William Dommel, Jr.]

NIH 91-130

2

Finally, the synthetic vaccines used were all manufactured in
France.
2) With respect to the evaluation of immunotherapy in the
treatment of AIDS:
This trial was approved on May 20, 1987 by the National Ethics
Committee, together with recommendations concerning the criteria of
the selection of patients whose "expectancy of survival beyond the
first 12 months was almost null with the treatments applicable at
present, and whose leukoneutropenia contraindicated any treatment
with AZT".
The clinical trial began in March 1989. It involved 22
patients.
The preliminary results led the organizers to request the
continuation of this trial and the Ethics Committee of the C.H.U.
St. Antoine [Hospital University Center) authorized this on May 29,
1990.
This purpose of this second phase was to compare the effects
of immunotherapy alone and/or associated with AZT in discontinuous
treatments, in order to detect an eventual decrease in its toxicity
and prolongation of its efficacy.
French and American reagents were used. The NIH provided
corresponding authorization on February 7, 1989 after an agreement
with the French Ministry of Health given on November 18, 1988.