A Safety, Tolerance, and Immunological Study of a Combination of Recombinant Interleukin 2 and Zidovudine in Patients With AIDS or AIDS Related Complex
AZT is an antiviral drug, which has been shown to be beneficial in some patients with AIDS.
IL-2 is a substance found naturally in the body that boosts the body's immune response to
invading organisms and tumor cells. These two drugs, when administered together, may have a
mutually helpful effect in treating AIDS patients, but before this effect can be studied, it
is important to understand the proper dose and any side effects that may occur when these
drugs are used together. The study will show how much AZT and IL-2 patients can safely take
at the same time and how the two drugs will interact with each other.
AMENDED: Note that the dose of AZT changed 900214 to reflect new dose recommendations.
Original design: Six weeks before beginning treatment with IL-2, patients are given AZT
daily. There are three patient groups, one for each dose level of IL-2. On the first day of
treatment with the two drugs together, patients are admitted to Presbyterian University
Hospital, where AZT is administered orally every 4 hours and IL-2 is given once a day as a
single injection under the skin. Clinical and laboratory safety data from the first two
patients enrolled in each treatment group will be analyzed prior to enrolling additional
patients in each group. All patients are expected to stay in the hospital for at least 5
days, and some may stay longer if serious side effects develop. AZT treatment will continue
after the patient leaves the hospital for an additional 10 weeks. Follow-up visits are
scheduled for days 6, 8, and 15 for safety, immunologic, and virologic evaluations.
Thereafter, patients are followed by telephone interview every other week and come into the
clinic if a change in health is reported. At weeks 10 and 20, patients are also evaluated in
a follow-up clinic visit.
Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government
|Univ of Pittsburgh Med School||Pittsburgh, Pennsylvania|