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.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Interferon alfa-2a Interferon alfa-2b Interferon alfa-n1 Interferons

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	074A
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002270 History of Changes
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

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Zidovudine
Polyomavirus Infections
Central Nervous System Viral Diseases
Infection
Reverse Transcriptase Inhibitors
Encephalitis, Viral

Anti-Retroviral Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Interferon-alpha
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Demyelinating Diseases
Growth Substances
Interferons
Acquired Immunodeficiency Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on November 05, 2009