Search / Trial NCT00001048

Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Leukoencephalopathy, Progressive Multifocal Infusions, Intravenous Cytarabine Zalcitabine Didanosine Drug Therapy, Combination Granulocyte Colony Stimulating Factor Acquired Immunodeficiency Syndrome Zidovudine Injections, Spinal

Description

The effectiveness of Ara-C in the treatment of PML, caused by a human DNA papovavirus (designated JC virus) infection, has not been determined, although the most encouraging results have occurred with intrathecal administration of the drug. Patients are randomized to receive antiretroviral therapy alone (AZT plus ddI or ddC), antiretroviral therapy plus intravenous Ara-C, or antiretroviral therapy plus intrathecal Ara-C. All patients receive 24 weeks of antiretroviral therapy. Beginning at week 2, patients on the intravenous Ara-C arm receive daily infusions of Ara-C over 5 days, with cycl...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Local intralesional chemotherapy for mucocutaneous Kaposi's sarcoma.
  • Topical antifungals, clotrimazole, ketoconazole, fluconazole, and amphotericin B for treatment of mucosal and esophageal candidiasis.
  • Foscarnet for newly developed CMV infection, only after discussion with the protocol chair.
  • Prophylactic and maintenance therapy for other opportunistic infections, provided patients are considered clinically stable.
  • No more than 1000 mg/day acyclovir for herpes simplex.
  • Antibiotics for bacterial infections as clinically indicated.
  • Antipyretics, analgesics, and antiemetics.
  • Concurrent Treatment:
  • Allowed:
  • Local radiation therapy for mucocutaneous Kaposi's sarcoma.
  • Patients must have:
  • HIV infection.
  • Confirmed PML.
  • No other current active opportunistic infections requiring systemic therapy.
  • Life expectancy of at least 3 months.
  • NOTE:
  • A durable power of attorney is recommended where severe neurologic or psychiatric impairment can be foreseen while the patient is on study.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Current active cryptococcal meningitis, cytomegaloviral encephalitis, toxoplasmosis encephalitis, CNS lymphoma, or neurosyphilis.
  • NOTE:
  • Patients on maintenance therapy for cryptococcal meningitis or toxoplasmosis encephalitis that has been stable for 4 months are permitted.
  • Conditions that seriously increase risk of a surgical procedure (e.g., coagulopathy, severe thrombocytopenia).
  • Any other disease that would interfere with evaluation of the patient.
  • Other life-threatening complications likely to cause death in < 3 months.
  • Concurrent Medication:
  • Excluded:
  • Ganciclovir.
  • Interferon.
  • Systemic chemotherapy other than Ara-C (unless specifically allowed).
  • Antiretroviral medications other than AZT, ddI, or ddC.
  • Patients with the following prior conditions are excluded:
  • History of allergy or intolerance to G-CSF.
  • Prior Medication:
  • Excluded:
  • Any prior Ara-C.
  • Excluded within 14 days prior to study:
  • Ganciclovir or foscarnet.
  • Interferon.
  • Antiretroviral medications other than AZT, ddI, or ddC.
  • Experimental medications for treatment of PML.

Attachments

readout_NCT00001048_2023-12-10.pdf

4.5 MB

NCT00001048_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Aurora, Colorado, United States

Miami, Florida, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Saint Louis, Missouri, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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