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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb Upjohn |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001048 |
To compare the safety and efficacy of antiretroviral therapy (zidovudine plus either didanosine or dideoxycytidine) versus antiretroviral therapy plus intravenous cytarabine (Ara-C) versus antiretroviral therapy plus intrathecal Ara-C in the maintenance or improvement of neurological function over 6 months in HIV-infected individuals who have developed progressive multifocal leukoencephalopathy (PML). To compare the effect of these three treatment regimens on Karnofsky score and MRI studies.
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.
Condition | Intervention | Phase |
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HIV Infections Leukoencephalopathy, Progressive Multifocal |
Drug: Filgrastim Drug: Cytarabine Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Multicenter Study Comparing Antiretroviral Therapy Alone to Antiretroviral Therapy Plus Cytosine Arabinoside (Cytarabine; Ara-C) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in Human Immunodeficiency Virus (HIV)-Infected Subjects |
Estimated Enrollment: | 90 |
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 cycles repeating every 21 days. Patients on the intrathecal Ara-C arm receive single administrations of Ara-C at weeks 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, and 24. A brain biopsy confirmation or in situ hybridization will be required within 7 days after study entry. Patients are followed every 4 weeks.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
NOTE:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
History of allergy or intolerance to G-CSF.
Prior Medication:
Excluded:
Excluded within 14 days prior to study:
United States, California | |
San Francisco AIDS Clinic / San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Connecticut | |
Yale Univ / New Haven | |
New Haven, Connecticut, United States, 065102483 | |
United States, District of Columbia | |
Georgetown Univ Med Ctr | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 331361013 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Harvard (Massachusetts Gen Hosp) | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
Columbia Presbyterian Med Ctr | |
New York, New York, United States, 100323784 | |
Adirondack Med Ctr at Saranac Lake | |
Albany, New York, United States, 122083479 | |
Mid - Hudson Care Ctr | |
Albany, New York, United States, 122083479 | |
Albany Med College / Division of HIV Medicine A158 | |
Albany, New York, United States, 122083479 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 | |
United States, Ohio | |
Univ of Kentucky Lexington | |
Cincinnati, Ohio, United States, 45267 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 981224304 |
Study Chair: | Hall C | |
Study Chair: | Timpone J |
Study ID Numbers: | ACTG 243 |
Study First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00001048 |
Health Authority: | United States: Federal Government |
Leukoencephalopathy, Progressive Multifocal Infusions, Intravenous Cytarabine Zalcitabine Didanosine |
Drug Therapy, Combination Granulocyte Colony-Stimulating Factor Acquired Immunodeficiency Syndrome Zidovudine Injections, Spinal |
Sexually Transmitted Diseases, Viral Demyelinating Diseases Zalcitabine Acquired Immunodeficiency Syndrome Zidovudine Leukoencephalopathy, Progressive Multifocal Polyomavirus Infections Central Nervous System Diseases Demyelinating diseases Progressive multifocal leukoencephalopathy |
Immunologic Deficiency Syndromes Encephalitis Virus Diseases Didanosine Central Nervous System Infections HIV Infections Sexually Transmitted Diseases DNA Virus Infections Retroviridae Infections Cytarabine |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases |
Enzyme Inhibitors Central Nervous System Viral Diseases Infection Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Encephalitis, Viral Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |