Main land US : Enrollment of subject from the REDS (SF area) study has begun. Of the 15 eligible REDS women, five have been enrolled thus far and 2 additional women have refused enrollment. The REDS enrollment at the three REDS blood banks which are RED Cross affiliated has been delayed by the necessity to obtain Human Subjects' approval by the central Red Cross Office. However, the REDS study Steering Committee has given approval to enrollment of the women, and the NIH project officer, George Nemo, Ph.D. has approved enrollment of subjects through the REDS mechanism. A total of eight other subjects has been identified at other Red Cross blood centers. The American Red Cross requires another approval by the central Red Cross Human Subjects' Committee before enrolling. This application was submitted in early January 1994, however, their committee meets only irregularly and a final approval has not yet been obtained. We expect such approval by the end of February.
Hawaii : We h
ave encountered delays in beginning enrollment at the Hawaii site due to the logistics of establishing the study infrastructure at this site distant from the Japanese and American primary investigators. However, the designation of Mary Flynn, M.D., the new Medical Director of the Blood Bank of Hawaii, as the person primarily responsible for the study has greatly facilitated these problems. Dr.Flynn has taken charge of the initial arrangements, including setting up of budgetary arrangements, and the designation of a skilled research technician who was recently laid off from the blood bank to perform the study enrollments. The study protocol is currently under review from the Human Subjects' Review Committee of the Blood Bank of Hawaii. As soon as this review is completed, we intend to begin enrollment of subjects. The updated total of HTLV-1 infected Japanese-American women eligible for the study in Hawaii is now 35. Nagasaki : Approval of the Human Right Committee of Nagasaki University has been obtained. Using ATL Prevention Program (APP) at Nagasaki, approximately 25 of 50 planned women have been already enrolled.
b. Study Headquarters at UCSF
Procedures for processing blood samples according to the red blood cell lysis protocol have been established and are in place both in Nagasaki and in San Francisco. It is planned that the other American sites will send their samples by overnight mail to the UCSF laboratory of Dr.Murphy for preservation of white blood cell pellets as well as plasma specimens. Additional preliminary studies on quantitative PCR on HTLV-1 specimens have been accomplished and show a correlation between HTLV-1 viral load and HTLV-1 antibody titer.