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

This study has been completed.
Study NCT00001048.   Last updated on July 29, 2008.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Detailed 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 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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Leukoencephalopathy, Progressive Multifocal
Intervention  Drug: Filgrastim
Drug: Cytarabine
Drug: Zidovudine
Drug: Zalcitabine
Drug: Didanosine
MEDLINE PMIDs 11364014,   10588116,   10360779,   9571254
Links Click here for more information about Zidovudine This link exits the ClinicalTrials.gov site
Click here for more information about Didanosine This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  90
Start Date 
Completion Date
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.
Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001048
Organization ID ACTG 243
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators †† Bristol-Myers Squibb
Upjohn
Investigators 
Study Chair:     Hall C        
Study Chair:     Timpone J        
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date July 1996
First Received Date  November 2, 1999
Last Updated Date July 29, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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