A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposi's Sarcoma

Trial Information

A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposi's Sarcoma

Patients are stratified by CD4 count, viral load, and prior systemic chemotherapy. Patients
are randomized equally to receive either IM862 or placebo given intranasally every other
day. Patients are seen every 4 weeks for 6 months or until disease progression to evaluate
toxicity and efficacy. Quality of life is assessed before treatment, then every month for 6
months. At the end of the 6-month study evaluation period, patients with PR/CR (responders)
remain on study and continue blinded treatment for an additional 6 months. For patients with
stable disease (non-responders), the treatment assignment is unblinded and off-study IM862
compassionate use is offered for 6 months, regardless of treatment group. For patients with
documented progressive disease (treatment failure), the treatment assignment is unblinded
and off-study IM862 is offered for 6 months to any patient in the placebo group. For
treatment failures in the IM862 group, IM862 is stopped and the patient is allowed other
therapy options.