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Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma

Phase 2
12 Years
Not Enrolling
Sarcoma, Kaposi, HIV Infections

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Trial Information

Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma

In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with
AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In
addition, it appeared that there was a substantial reduction in KS lesions with this
therapy. Potential benefits of this combined therapy include resolution of KS lesions,
prolonged survival, a decrease in the frequency and severity of opportunistic infections,
improvement in CD4 cells, and a decrease in serum p24 antigens.

Following evaluation studies, patients who participate in the study receive IFN-A2a and AZT.
IFN-A2a is administered as a single subcutaneous injection once a day. AZT is given in a
single capsule every 4 hours through the day for a total of six capsules. The first phase of
treatment continues for 8 weeks followed by a 1-week rest period, during which time AZT only
is given. Subjects who have had an interruption in interferon during the first 8 weeks of
the study for a toxicity may skip the rest period. Patients experiencing a complete response
will be placed on maintenance therapy. Patients without progression of their KS can continue
on the treatment of AZT and IFN-A2a until a complete response is obtained or until study is
terminated, whichever comes first. Patients with complete anti-tumor response can continue
on a maintenance phase, in which they receive IFN-A2a as a single injection 3 times a week
on nonconsecutive days and a single capsule of AZT q4h 6 x /day until the study is
terminated on February 1, 1992. Patients are required to visit the clinic weekly for the
first 12 weeks (except during the week 9 rest period), every other week for the next 8
weeks, every month for up to 52 weeks of the study and every 3 months thereafter. Throughout
the study, frequent blood samples will be taken to monitor the effectiveness and safety of
the treatment.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- Inhalation pentamidine for the prevention of Pneumocystis carinii pneumonia (PCP) at
a dose of 300 mg once every 4 weeks.

- AMENDED: Trimethoprim - sulfamethoxazole or dapsone only if on the maintenance phase
of the study.

Concurrent Treatment:


- Blood transfusions.

Patients must have a positive antibody to HIV by any federally licensed ELISA test. All
lab tests must be within 7 days of entry into the study.

Exclusion Criteria

Concurrent Medication:


- Other antiretroviral agents.

- Immunomodulators.

- Corticosteroids.

- Cytotoxic chemotherapy.

- Aspirin.

- H2 blockers.

- Barbiturates and myelosuppressive drugs should be particularly avoided as they may
interfere with the metabolism or enhance the toxicities of either zidovudine or
interferon alfa-2a.

- Other experimental medications.

Concurrent Treatment:


- Radiation therapy.

Patients with prior experience of Grade 4 toxicity to zidovudine therapy will be excluded
from the study.

Prior Medication:


- Interferon therapy.

- Excluded within 30 days of study entry:

- Immunomodulators.

- Corticosteroids.

- Cytotoxic chemotherapeutic agents.

- Excluded within 14 days of study entry:

- Zidovudine (AZT).

Prior Treatment:

Excluded within 30 days of study entry:

- Blood transfusions.

- Radiation therapy.

Patients may not have any of the following diseases or symptoms:

- Active opportunistic infection associated with AIDS.

- Significant neurologic disease associated with AIDS, as manifested by motor
abnormalities including impaired rapid eye movement or ataxia, motor weakness in the
lower extremities, sensory deficit consistent with a peripheral neuropathy, bladder
or bowel incontinence.

- Internal organ involvement with Kaposi's sarcoma, i.e., nonnodal visceral Kaposi's
sarcoma, excluding minimal gastrointestinal disease of less than 5 lesions.

- Tumor-associated edema.

- Current neoplasm other than Kaposi's sarcoma.

- Significant cardiac disease, including a recent history of myocardial infarction or
significant current cardiac arrhythmias.

Active drug or alcohol abuse.

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

M Fischl

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 096



Start Date:

Completion Date:

July 1993

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Interferon Alfa-2a
  • Drug Evaluation
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma



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Johns Hopkins Adult AIDS CRS Baltimore, Maryland  21287
Beth Israel Deaconess - East Campus A0102 CRS Boston, Massachusetts  02215
Washington U CRS St. Louis, Missouri  
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Univ. of Rochester ACTG CRS Rochester, New York  14642
Case CRS Cleveland, Ohio  44106
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Pitt CRS Pittsburgh, Pennsylvania  15213