Pharmacodynamics of Intermittent IL-2 Infusions in HIV Seropositive Patients
Status:
Completed
Trial end date:
2002-03-01
Target enrollment:
Participant gender:
Summary
This study is designed as a randomized, open trial of intermittent continuous infusions of
Interleukin-2 in HIV seropositive patients with a CD4 cell count between 200 and 500
cells/mm(3). The goal of the study is to determine the optimal duration of each infusion, and
the optimal interval between infusions. Thirty-six patients will be randomized to 3 groups:
Group A will be the control group with a regimen of five day infusions of IL-2 every eight
weeks; Group B will receive IL-2 infusions every eight weeks, however the duration of each
infusion will be determined by parameters reflecting T cell proliferation, with
discontinuation of each infusion at a point when the response appears to be maximized; Group
C will receive five day infusions of IL-2; however the interval between infusions will be
determined by the response seen to the prior infusion, with the goal of administering
infusions while the CD4 cell count remains above baseline from the prior infusion. The dose
of interleukin-2 to be used will be 9 MIU by continuous infusion daily. All patients will be
evaluated at the NIH at least every 4 weeks, and at that time safety labs and immune studies
will be performed. In addition, patients in Groups B and C will undergo a laboratory
evaluation weekly, at which time immune parameters, including CD4 number and percent,
spontaneous blast transformation, soluble IL-2 receptor levels, and viral parameters,
including branched DNA assay and p24 antigen, will be determined. The study duration will be
approximately one year.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)