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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

This study has been completed.

Sponsored by: Bayer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002238
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Interferon beta-1b
Drug: Zidovudine
Phase III

MedlinePlus related topics:   AIDS   

Drug Information available for:   Zidovudine    Interferon alfa-2b    Interferons    Interferon beta    Interferon-beta    Interferon beta-1b   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind
Official Title:   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
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002238

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

Sponsors and Collaborators
Bayer
  More Information


Study ID Numbers:   002A, TBO1-310188
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002238
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination  
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  
Zidovudine  
Interferon Type I  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Interferons
Interferon-beta
Zidovudine
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Interferon beta-1b
Retroviridae Infections
Interferon Alfa-2b

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




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