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A Pilot Study of the Efficacy of Recombinant Alpha Interferon (IFN-A2b) and Zidovudine (AZT) in the Treatment of Progressive Multifocal Leukoencephalopathy (PML) Complicating HIV-1 Infection

This study has been completed.

Sponsored by: University of Miami
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002270
  Purpose

To study the effectiveness of alpha interferon (IFN-A2b) and zidovudine (AZT) in treating progressive multifocal leukoencephalopathy (PML) as a complication of HIV-1 infection.


Condition Intervention
HIV Infections
Leukoencephalopathy, Progressive Multifocal
Drug: Interferon alfa-2b
Drug: Zidovudine

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Zidovudine    Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Dose Comparison
Official Title:   A Pilot Study of the Efficacy of Recombinant Alpha Interferon (IFN-A2b) and Zidovudine (AZT) in the Treatment of Progressive Multifocal Leukoencephalopathy (PML) Complicating HIV-1 Infection
  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients must have:

  • HIV seropositivity by both ELISA and Western blot.
  • Biopsy proven progressive multifocal leukoencephalopathy (PML).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Intolerant to interferon.
  • Prior or concomitant central nervous system disease (CNS) such as toxoplasmosis, multiple sclerosis (MS), or neurosyphilis.

Patients with the following are excluded:

  • Intolerant to interferon.
  • Prior or concomitant central nervous system disease (CNS) such as toxoplasmosis, multiple sclerosis (MS), or neurosyphilis.

Prior Medication:

Excluded:

  • Patients receiving interferon for other reasons.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002270

Locations
United States, Florida
Univ of Miami School of Medicine    
      Miami, Florida, United States, 33136

Sponsors and Collaborators
University of Miami
  More Information

Study ID Numbers:   074A
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002270
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Leukoencephalopathy, Progressive Multifocal  
Interferon Alfa-2b  
Drug Evaluation  
Acquired Immunodeficiency Syndrome  
Zidovudine  

Study placed in the following topic categories:
Interferon-alpha
Sexually Transmitted Diseases, Viral
Demyelinating Diseases
Interferons
Acquired Immunodeficiency Syndrome
Zidovudine
Leukoencephalopathy, Progressive Multifocal
Polyomavirus Infections
Central Nervous System Diseases
Demyelinating diseases
Progressive multifocal leukoencephalopathy
Immunologic Deficiency Syndromes
Encephalitis
Virus Diseases
Central Nervous System Infections
HIV Infections
Sexually Transmitted Diseases
DNA Virus Infections
Interferon Alfa-2a
Interferon Alfa-2b
Retroviridae Infections

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

ClinicalTrials.gov processed this record on August 21, 2008




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