A Phase I/II Study of the Combination of Azidothymidine and Interleukin-2 (IL-2) in the Treatment of HIV-Infected Patients
Status:
Completed
Trial end date:
2002-04-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the long-term toxicity and obtain preliminary information about
long-term efficacy of the combination of antiretroviral therapies and interleukin-2 (IL-2), a
cytokine with immunomodulatory properties. Currently 73 patients have been approved to
receive IL-2 at a starting dose of 18 MIU/d for 5 days. Multiple courses of IL-2 will be
administered, at approximately 2 month intervals. Clinical, laboratory, immunologic, and
viral parameters will be closely monitored during this time for evidence of toxicity and
preliminary evidence of efficacy.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)