NCT00002270

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 1991

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV InfectionsLeukoencephalopathy, Progressive Multifocal

Keywords

Leukoencephalopathy, Progressive MultifocalInterferon Alfa-2bDrug EvaluationAcquired Immunodeficiency SyndromeZidovudine

Interventions

Interferon alfa-2bDRUG
ZidovudineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ of Miami School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

HIV InfectionsLeukoencephalopathy, Progressive MultifocalAcquired Immunodeficiency Syndrome

Interventions

Interferon alpha-2Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectious EncephalitisPolyomavirus InfectionsDNA Virus InfectionsSlow Virus DiseasesEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesLeukoencephalopathiesDemyelinating DiseasesNeuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Interferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1991-03

Locations

US(1)