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A Safety, Tolerance, and Immunological Study of a Combination of Recombinant Interleukin 2 and Zidovudine in Patients With AIDS or AIDS Related Complex


Phase 1
18 Years
50 Years
Not Enrolling
Both
HIV Infections

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Trial Information

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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

M Ho

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 067

NCT ID:

NCT00000986

Start Date:

Completion Date:

January 1994

Related Keywords:

  • HIV Infections
  • Recombinant Proteins
  • Interleukin-2
  • Drug Interactions
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Zidovudine
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • AIDS-Related Complex

Name

Location

Univ of Pittsburgh Med SchoolPittsburgh, Pennsylvania