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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

Primary Purpose

HIV Infections, Leukoencephalopathy, Progressive Multifocal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interferon alfa-2b
Zidovudine
Sponsored by
University of Miami
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Leukoencephalopathy, Progressive Multifocal, Interferon Alfa-2b, Drug Evaluation, Acquired Immunodeficiency Syndrome, Zidovudine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Miami School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT00002270
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 1991
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
University of Miami

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Leukoencephalopathy, Progressive Multifocal
Keywords
Leukoencephalopathy, Progressive Multifocal, Interferon Alfa-2b, Drug Evaluation, Acquired Immunodeficiency Syndrome, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Interferon alfa-2b
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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