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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002238
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
June 24, 2005
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No Changes Posted
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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
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
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.
Not Provided
Interventional
Phase 3
Masking: Double
Primary Purpose: Treatment
HIV Infections
  • Drug: Interferon beta-1b
  • Drug: Zidovudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002238
002A
TBO1-310188
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Bayer
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NIH AIDS Clinical Trials Information Service
April 1991

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP