The Safety and Effectiveness of Interleukin-2 Plus Zidovudine in Patients With AIDS or AIDS Related Complex
Condition: HIV Infections
MeSH terms: AIDS-Related Complex
Study type: Interventional
Phase: Phase 1

Summary: 
      To test the safety and tolerance of three different doses of recombinant human interleukin 2
      (aldesleukin; IL-2), when it is given for five consecutive days to patients with AIDS or AIDS
      related complex (ARC), who have also received zidovudine (AZT) for at least 6 weeks just
      before beginning the IL-2 treatment.

      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.
    

Detailed description: 
      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.
    

Intervention name(s): Zidovudine; Aldesleukin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zidovudine; Aldesleukin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recombinant Proteins; Interleukin-2; Drug Interactions; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine