The objectives of this study are to monitor all previously treated patients for long-term safety, duration of response and CD4 + T-cell count > 400/mm3. Any patient who has received treatment with chimeric Anti-CD4 will be monitored for serious adverse events, opportunistic infections, immunosuppressive and anti-infective medication history, lymphocyte recovery, and general disease status. Safety assessments are performed every 6 months until the absolute lymphocyte count (ALC) is > 400 cells/mm3 . We had five patients complete the randomized phase of the study and all patients have shown < 30 % decrease in their disease activity. All five patients received open-label chimeric Anti-CD4 treatment at the highest dose of 50 mg/day and there was no significant improvement in their disease activity. The randomized study was stopped prematurely because an interim analysis revealed no differences in efficacy between the placebo and treatment groups. We have completed the safety follow-up on all five of our patients. The study is closed.
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