Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen

June 23, 2005 updated by: Bayer
To evaluate the safety and efficacy of interferon beta (Betaseron) in AIDS and advanced AIDS related complex (ARC) patients receiving a reduced-dose zidovudine (AZT) regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates / Herrick Hosp
      • Los Angeles, California, United States, 90095
        • UCLA CARE Ctr
      • Los Angeles, California, United States, 90033
        • USC School of Medicine / Norris Cancer Hosp
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Med Ctr
      • Oakland, California, United States, 94609
        • Summitt Med Ctr / San Francisco Gen Hosp
      • Orange, California, United States, 92668
        • UCI Med Ctr
      • San Francisco, California, United States, 94114
        • Davies Med Ctr
      • San Jose, California, United States, 95128
        • Santa Clara Valley Med Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
      • Washington, District of Columbia, United States, 20016
        • Dr William Davis
    • Florida
      • Tampa, Florida, United States, 33612
        • Univ of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Hosp
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Med Ctr
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr / Peter Krueger Clinic
      • New York, New York, United States, 10021
        • Mem Sloan - Kettering Cancer Ctr
      • New York, New York, United States, 10016
        • Dr Douglas Dieterich
      • New York, New York, United States, 10014
        • Chelsea Village Med Ctr
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Univ Hosp of Cleveland / Case Western Reserve Univ
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Graduate Hosp
      • Philadelphia, Pennsylvania, United States, 191341095
        • Saint Christopher's Hosp for Children
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Med College
    • Texas
      • Galveston, Texas, United States, 77550
        • Univ TX Galveston Med Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Zidovudine (AZT).

Patient must have:

  • Uninterrupted therapy with reduced-dose AZT 500 - 600 mg/day for at least 3 weeks before entry.
  • Acceptable hepatic and renal function.
  • AMENDED to delete the following sentence:
  • Hematologic intolerance to full-dose zidovudine (AZT) (1000 - 1200 mg/day).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Concurrent, ineffectively controlled opportunistic infections.
  • Extensive cutaneous and/or visceral Kaposi's sarcoma requiring systemic chemotherapy.
  • Proteinuria of 2+ or greater.
  • HIV encephalopathy.
  • HIV wasting syndrome.
  • New York Heart Classification III or IV.
  • Uncontrolled angina pectoris.
  • Evidence of clinically significant, multifocal uncontrolled cardiac dysrhythmias.

Concurrent Medication:

Excluded:

  • Antiretrovirals other than zidovudine (AZT) or Betaseron.
  • Chronic acyclovir therapy.
  • Acetaminophen.

Patients with the following are excluded:

  • Intolerance (hematologic or otherwise) to zidovudine (AZT) at a dose of 100 mg orally every 4 hours. AMENDED to:
  • Intolerance at a dose of 500 to 600 mg/day.
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent or complete the study.

Prior Medication:

Excluded within 30 days of study entry:

  • Cytotoxic chemotherapy.
  • Prior therapy with alpha, beta, or gamma interferons.

Active drug or alcohol abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 1991

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002A
  • TBO1-310188

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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