Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients
NCT ID: NCT00001048
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
1997-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Filgrastim
Cytarabine
Zidovudine
Zalcitabine
Didanosine
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Upjohn
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Hall C
Role: STUDY_CHAIR
Timpone J
Role: STUDY_CHAIR
Locations
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University of Colorado Hospital CRS
Aurora, Colorado, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Northwestern University CRS
Chicago, Illinois, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Washington U CRS
St Louis, Missouri, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Countries
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References
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Cytarabine nixed for PML. GMHC Treat Issues. 1996 Nov;10(11):9.
Post MJ, Yiannoutsos C, Simpson D, Booss J, Clifford DB, Cohen B, McArthur JC, Hall CD. Progressive multifocal leukoencephalopathy in AIDS: are there any MR findings useful to patient management and predictive of patient survival? AIDS Clinical Trials Group, 243 Team. AJNR Am J Neuroradiol. 1999 Nov-Dec;20(10):1896-906.
Hall C, Timpone J, Dafni I, Antonijevic Z, Millar L, Booss J, Clifford D, Cohen B, McArthur J, Hollander H. ARA-C treatment of PML in AIDS patients. Conf Retroviruses Opportunistic Infect.1997 Jan 22-26;4th:66 (abstract no 8)PMID: 97926517
Yiannoutsos CT, Major EO, Curfman B, Jensen PN, Gravell M, Hou J, Clifford DB, Hall CD. Relation of JC virus DNA in the cerebrospinal fluid to survival in acquired immunodeficiency syndrome patients with biopsy-proven progressive multifocal leukoencephalopathy. Ann Neurol. 1999 Jun;45(6):816-21. doi: 10.1002/1531-8249(199906)45:63.0.co;2-w.
Hall CD, Dafni U, Simpson D, Clifford D, Wetherill PE, Cohen B, McArthur J, Hollander H, Yainnoutsos C, Major E, Millar L, Timpone J. Failure of cytarabine in progressive multifocal leukoencephalopathy associated with human immunodeficiency virus infection. AIDS Clinical Trials Group 243 Team. N Engl J Med. 1998 May 7;338(19):1345-51. doi: 10.1056/NEJM199805073381903.
Crit Path AIDS Proj 1994-95 Winer; (No 30): 28-29. A phase II Multicenter Study Comparing Antiretroviral Therapy Alone to Antiretroviral Therapy Plku Cytosine Arabinosine (Cytarabine; Ara-C) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in Human Immunodeficiency Virus (HIV)-Infected Subjects. .
Other Identifiers
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11220
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 243
Identifier Type: -
Identifier Source: org_study_id