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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002270
First Posted: August 31, 2001
Last Update Posted: December 9, 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
  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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002270


Locations
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
  More Information

ClinicalTrials.gov Identifier: NCT00002270     History of Changes
Other Study ID Numbers: 074A
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: March 1991

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Leukoencephalopathies
Leukoencephalopathy, Progressive Multifocal
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
Polyomavirus Infections
DNA Virus Infections
Slow Virus Diseases
Infectious Encephalitis
Encephalitis
Central Nervous System Infections
Demyelinating Diseases
Interferons
Interferon-alpha
Zidovudine
Antineoplastic Agents
Antiviral Agents