The Safety and Effectiveness of Interferon Alfa-2B Plus Didanosine in Patients With Kaposi's Sarcoma
Status:
Completed
Trial end date:
2000-03-01
Target enrollment:
Participant gender:
Summary
Primary: To evaluate the safety, toxicity, and antitumor activity of two doses of interferon
alfa-2b (IFN-alpha) combined with a fixed dose of didanosine (ddI) in patients with Kaposi's
sarcoma associated with HIV infection.
Secondary: To evaluate the effects of combined IFN-alpha and ddI treatment on HIV expression
and markers of immune function.
Previous studies have shown that IFN-alpha can induce regression of Kaposi's sarcoma and
suppression of HIV in some patients. Although various trials using IFN-alpha in combination
with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor activity
and evidence of HIV suppression, the overlapping toxicity (primarily neutropenia) of these
two agents has proven dose-limiting. The toxicity profile of ddI suggests that this drug may
be better tolerated than zidovudine when combined with IFN-alpha.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)