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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

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ClinicalTrials.gov Identifier: NCT00000687
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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
Sarcoma, Kaposi HIV Infections Drug: Interferon alfa-2a Drug: Zidovudine 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
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
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 : July 1993

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000687


Locations
United States, Florida
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136
United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington U CRS
St. Louis, Missouri, United States
United States, New York
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States, 10003
Univ. of Rochester ACTG CRS
Rochester, New York, United States
United States, Ohio
Case CRS
Cleveland, Ohio, United States, 44106
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Pitt CRS
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: M Fischl
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000687     History of Changes
Other Study ID Numbers: ACTG 096
11071 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Interferon Alfa-2a
Drug Evaluation
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Zidovudine

Additional relevant MeSH terms:
HIV Infections
Sarcoma
Sarcoma, Kaposi
AIDS-Related Opportunistic Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Herpesviridae Infections
DNA Virus Infections
Neoplasms, Vascular Tissue
Opportunistic Infections
Infection
Parasitic Diseases
Interferons
Interferon-alpha
Zidovudine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites