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”

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.

Intervention(s) in this Clinical Trial

• Drug: Interferon alfa-2b
• Drug: Zidovudine

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Miami Other

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002270

Study ID Number: 074A

ClinicalTrials.gov Identifier: NCT00002270

Health Authority: United States: Food and Drug Administration