Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
12 Years
N/A
Both
Sarcoma, Kaposi, HIV Infections
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:
Allowed:
- 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:
Allowed:
- 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:
Excluded:
- 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:
Excluded:
- Radiation therapy.
Patients with prior experience of Grade 4 toxicity to zidovudine therapy will be excluded
from the study.
Prior Medication:
Excluded:
- 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:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
M Fischl
Investigator Role:
Study Chair
Authority:
United States: Federal Government
Study ID:
ACTG 096
NCT ID:
NCT00000687
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
Name | Location |
|---|---|
| Univ. of Miami AIDS CRS | Miami, Florida 33136 |
| Johns Hopkins Adult AIDS CRS | Baltimore, Maryland 21287 |
| Beth Israel Deaconess - East Campus A0102 CRS | Boston, Massachusetts 02215 |
| Washington U CRS | St. Louis, Missouri |
| Beth Israel Med. Ctr. (Mt. Sinai) | New York, New York 10003 |
| Univ. of Rochester ACTG CRS | Rochester, New York 14642 |
| Case CRS | Cleveland, Ohio 44106 |
| The Ohio State Univ. AIDS CRS | Columbus, Ohio 43210 |
| Pitt CRS | Pittsburgh, Pennsylvania 15213 |
