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

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00000687
Collaborator
(none)
60
9
6.7

Study Details

Study Description

Brief Summary

To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time.

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
Actual Study Completion Date :
Jul 1, 1993

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Univ. of Miami AIDS CRS Miami Florida United States 33136
    2 Johns Hopkins Adult AIDS CRS Baltimore Maryland United States 21287
    3 Beth Israel Deaconess - East Campus A0102 CRS Boston Massachusetts United States 02215
    4 Washington U CRS Saint Louis Missouri United States
    5 Beth Israel Med. Ctr. (Mt. Sinai) New York New York United States 10003
    6 Univ. of Rochester ACTG CRS Rochester New York United States
    7 Case CRS Cleveland Ohio United States 44106
    8 The Ohio State Univ. AIDS CRS Columbus Ohio United States 43210
    9 Pitt CRS Pittsburgh Pennsylvania United States

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Study Chair: M Fischl,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT00000687
    Other Study ID Numbers:
    • ACTG 096
    • 11071
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2021