The Safety and Effectiveness of Interleukin-2 Plus Zidovudine in Patients With AIDS or AIDS Related Complex
NCT00000986 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2021-11-04
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.
Conditions
- HIV Infections
Interventions
- DRUG
-
Zidovudine
- DRUG
-
Aldesleukin
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
lead NIH
Principal Investigators
-
M Ho
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Completion
- 1994-01-31
Countries
- United States
Study Locations
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