Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma
IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the
test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV
reverse transcriptase; Phase I and II study benefits of AZT treatment include increased
objective clinical improvement, decreased mortality rate, and decreased incidence of
opportunistic infections. Long-term AZT use, however, presents possible limitations
secondary to intolerance. This study, therefore, will investigate the potential antiviral
activities of a combination of IFN-B and AZT to determine the safety and efficacy of such
treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination
drug therapy consisting of low doses of each drug will reduce the potential of toxicity,
treatment failures, and disease recurrences resulting from drug-resistant virus mutants.
Patients undergo evaluations to determine the extent of their disease and the status of
their immune system. Patients then receive IFN-B subcutaneously once a day at one of three
different dose levels. Patients also take AZT at 1 of 2 doses. The first 12 patients are
treated with the lower dose of AZT. The first 4 patients are entered at level 1 of IFN-B. If
no dose-limiting toxicity is seen in these 4 patients after 2 weeks of therapy, 4 patients
are then enrolled at level 2 of IFN-B. The study proceeds in this manner until the highest
tolerated dose or level 3 is reached. If both drugs are tolerated, patients then remain on
both medications as long as they continue to tolerate the medications and show some
improvement in either antiviral response, immune response, or clinical response for as long
as 24 weeks. The initial three doses of IFN-B are given to each patient at the study site
during which time the patient is trained to self-administer the IFN-B. Patients are then
seen weekly for 4 months and every 2 weeks thereafter.
Interventional
Masking: Open Label, Primary Purpose: Treatment
S Miles
Study Chair
United States: Federal Government
ACTG 057
NCT00000695
July 1991
Name | Location |
---|---|
Los Angeles County - USC Med Ctr | Los Angeles, California 90033 |
UCLA CARE Ctr | Los Angeles, California 90095 |
Northwestern Univ Med School | Chicago, Illinois 60611 |
USC School of Medicine / Norris Cancer Hosp | Los Angeles, California 90033 |