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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000986 |
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.
Condition | Intervention | Phase |
HIV Infections |
Drug: Zidovudine Drug: Aldesleukin |
Phase I |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Zidovudine Aldesleukin Interleukin-2 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Safety, Tolerance, and Immunological Study of a Combination of Recombinant Interleukin 2 and Zidovudine in Patients With AIDS or AIDS Related Complex |
Estimated Enrollment: | 18 |
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Prior Medication:
Required for at least 6 weeks prior to study entry:
Patients must demonstrate the following clinical and laboratory findings:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions will be excluded:
Concurrent Medication:
Excluded:
Patients with the following conditions will be excluded:
Prior Medication:
Excluded within 4 weeks of study entry:
Active drug or alcohol abuse.
Click here for more information about Zidovudine 
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Click here for more information about Aldesleukin 
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Study ID Numbers: | ACTG 067 |
First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000986 |
Health Authority: | United States: Federal Government |
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