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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 Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Comparison of Anti HIV Drugs Used Alone or in Combination with Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Comparison of Anti HIV Drugs Used Alone or in Combination with Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients Clinical research trials and Comparison of Anti HIV Drugs Used Alone or in Combination with Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Comparison of Anti HIV Drugs Used Alone or in Combination with Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients. Comparison of Anti HIV Drugs Used Alone or in Combination with Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Comparison of Anti HIV Drugs Used Alone or in Combination with Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients clinical trial. Human subjects frequently get the finest healthcare available for their Comparison of Anti HIV Drugs Used Alone or in Combination with Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Comparison of Anti HIV Drugs Used Alone or in Combination with Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients  Comparison of Anti HIV Drugs Used Alone or in Combination with Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients
Comparison of Anti HIV Drugs Used Alone or in Combination with Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients
For Condition: HIV Infections,Leukoencephalopathy, Progressive Multifocal
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb,Upjohn
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
HallC, Study Chair,
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Mid - Hudson Care Ctr
Albany, New York, 122083479
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Columbia Presbyterian Med Ctr
New York City, New York, 100323784
United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Adirondack Med Ctr at Saranac Lake
Albany, New York, 122083479
United States
Additional Information:
Study ID Numbers: ACTG 243;
Study Start Date:
Record last reviewed: July 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001048
Other Hiv Infections Studies:
1. Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
2. A Phase I/II Pilot Study of Simultaneously Administered rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility
3. A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
4. Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients
5. Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
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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
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