Completed

The Safety and Effectiveness of Interleukin-2 Plus Zidovudine in Patients With AIDS or AIDS Related Complex

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What is being tested

Zidovudine

+ Aldesleukin
Drug
Who is being recruted

HIV Infections

From 18 to 50 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleA Safety, Tolerance, and Immunological Study of a Combination of Recombinant Interleukin 2 and Zidovudine in Patients With AIDS or AIDS Related Complex 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
18 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 50 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

Inclusion Criteria Concurrent Medication: Allowed: * Acetaminophen under the supervision of a study physician. Prior Medication: Required for at least 6 weeks prior to study entry: * Zidovudine at a dose of at least 300 mg/day. * Allowed: * Aerosolized pentamidine prior to combination therapy. Patients must demonstrate the following clinical and laboratory findings: * Currently receiving zidovudine (AZT) at a dose of at least 300 mg/day and have received the drug for at least 6 weeks. * Have a life expectancy of = or \> 4 months. * Available for the duration of the study and for follow-up visits. Exclusion Criteria Co-existing Condition: Patients with the following conditions will be excluded: * Evidence of active life-threatening opportunistic infection with bacterial, viral, fungal, or protozoan pathogens during the 6-week period prior to and during the 5-day period of combination therapy. * A fever \> 101 degrees F within the past 10 days. * Significant central nervous system disease, including acquired immunodeficiency syndrome (AIDS), dementia, psychiatric disabilities, or seizure disorders. * Significant cardiac (New York Heart Association stage III or IV) and/or pulmonary disease (forced expiratory volume \< 75 percent). * Kaposi's sarcoma or other AIDS related malignancy. * Evidence of malabsorption as indicated by 10 percent weight loss within the last 3 months. Concurrent Medication: Excluded: * Cardiac medications. * Glucocorticosteroids. * Probenecid. * Acetylsalicylic acid. * Trimethoprim / sulfamethoxazole. * Acyclovir. * Allopurinol. * Drugs causing anemia, neutropenia, or nephrotoxicity. * Aerosolized pentamidine during combination therapy. * Nonsteroidal anti-inflammatory drugs by patients with thrombocytopenia (\<75000 platelets/mm3). * Acetaminophen except under supervision of a study physician. Patients with the following conditions will be excluded: * Evidence of active life-threatening opportunistic infection with bacterial, viral, fungal, or protozoan pathogens during the 6-week period prior to and during the 5-day period of combination therapy. * A fever \> 101 degrees F within the past 10 days. * Significant central nervous system disease, including acquired immunodeficiency syndrome (AIDS), dementia, psychiatric disabilities, or seizure disorders. * Significant cardiac (New York Heart Association stage III or IV) and/or pulmonary disease (forced expiratory volume \< 75 percent). * Kaposi's sarcoma or other AIDS related malignancy. * Evidence of malabsorption as indicated by 10 percent weight loss within the last 3 months. Prior Medication: Excluded within 4 weeks of study entry: * Any antiretroviral drug, except zidovudine (AZT). * Excluded within 12 weeks of study entry: * Immunotherapy, including interleukins, interferons, tumor necrosis factor. * Other cytokines. * Biologic response modifiers. * Monoclonal antibodies. * BCG vaccines. Active drug or alcohol abuse.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Univ of Pittsburgh Med SchoolPittsburgh, United StatesSee the location

CompletedOne Study Center