Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients
Completed · Phase 2
Conditions studied: HIV Infections, Leukoencephalopathy, Progressive Multifocal
In brief
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.
Key facts
- Study ID
- NCT00001048
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 90
- Expected to finish
- 1997-04-01
- Last updated by the study team
- 2021-11-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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