National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch, 6701 Rockledge Drive, Room 6100, MSC 7902, Bethesda, MD 20892

A -- PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIAL (BABY HUG) CLINICAL CENTERS SOL NHLBI-HB-00-01 DUE 083099 POC Joann A. Ciufolo, Contracting Officer, 301-435-0359 E-MAIL: Joann A. Ciufolo, Contracting Officer, ciufoloj@nih.gov. The National Heart, Lung, & Blood Institute (NHLBI) will issue RFP No. NHLBI-HB-00-01 on or about June 30, 1999. It is anticipated that multiple six-year cost reimbursement completion awards will be made on or about June 1, 2000. The contractor shall serve as a Clinical Center (CC) for the multicenter Pediatric Hydroxyurea Phase III Clinical Trial. The objective of this double-blind, placebo-controlled trial is to test the hypothesis that Hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia (HbSS). Study design will test the efficacy of hydroxyurea in preventing the onset of organ damage in very young children recruited between 6 and 24 months of age. The study will involve 100 children with HbSS in each study arm to receive either hydroxyurea or placebo. Children will be evaluated annually for changes in brain function, pulmonary function, renal function, growth and development milestones, and quality of life. Approximately 10pediatric clinical centers, a medical coordinating center, a clinical pharmacy/drug distribution center, and a blood chemistry laboratory will participate in this study. Responsibilities include, but are not limited to, the following: 1) Participate as a member of the steering committee in the development and finalization of the study protocol; 2) enroll and follow at least 20 children between the ages of 6 months and 2 years with sickle cell disease; 3) perform patient entry tests and forward blood samples to the Blood and Chemistry Laboratory; 5) transmit complete and accurate patient clinical data to the Medical Coordinating Center; 6) participate in committee and subcommittee meetings; 7) oversee exit of the trial subjects from the clinical trial; and 8) participate in analysis of data and writing of trial papers. RFP No. NHLBI-HB-00-01 will be released on the NHLBI web page at http://www.nhlbi.nih.gov/nhlbi/rafs/rfas.htm . There are no paper copies. Interested organizations should review and download the streamlined RFP designated as RFP No. NHLBI-HB-00-01 which will appear under the list of RFPS for the National Heart, Lung, and Blood Institute. Posted 06/15/99 (W-SN343216). (0166)

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