Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients

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

The purpose of this study is to see if it is safe and effective to use IM862 to treat Kaposi's sarcoma (KS) in AIDS patients.

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.

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.
• Have AIDS-related Kaposi's sarcoma.
• Have at least 5 skin or mouth sores that do not require chemotherapy.
• Have been taking anti-HIV drugs for at least 8 weeks before study entry with no changes in the regimen.
• Are at least 18 years old.
• Agree to practice effective methods of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have an AIDS-related opportunistic infection (except for genital herpes) within 2 weeks of study entry.
• Have had another type of cancer within the past 2 years (except for certain types of skin cancer, cervical cancer, or anal cancer).
• Have a severe chest cold.
• Have certain other serious medical conditions.
• Have received certain medications, including chemotherapy, within the past 4 weeks.
• Abuse alcohol or drugs.
• Are pregnant or breast-feeding.