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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

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Interferon alfa-2a
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Interferon Alfa-2a, Drug Evaluation, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ. of Miami AIDS CRS
  • Johns Hopkins Adult AIDS CRS
  • Beth Israel Deaconess - East Campus A0102 CRS
  • Washington U CRS
  • Beth Israel Med. Ctr. (Mt. Sinai)
  • Univ. of Rochester ACTG CRS
  • Case CRS
  • The Ohio State Univ. AIDS CRS
  • Pitt CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 26, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000687
Brief Title
Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
Official Title
Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1993 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Interferon Alfa-2a, Drug Evaluation, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Interferon alfa-2a
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Fischl
Official's Role
Study Chair
Facility Information:
Facility Name
Univ. of Miami AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Johns Hopkins Adult AIDS CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Beth Israel Deaconess - East Campus A0102 CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Beth Israel Med. Ctr. (Mt. Sinai)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
Country
United States
Facility Name
Case CRS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State Univ. AIDS CRS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Pitt CRS
City
Pittsburgh
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8601224
Citation
Fischl MA, Finkelstein DM, He W, Powderly WG, Triozzi PL, Steigbigel RT. A phase II study of recombinant human interferon-alpha 2a and zidovudine in patients with AIDS-related Kaposi's sarcoma. AIDS Clinical Trials Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Apr 1;11(4):379-84. doi: 10.1097/00042560-199604010-00008.
Results Reference
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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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