Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
NCT ID: NCT00002395
Last Updated: 2005-06-24
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
54 participants
INTERVENTIONAL
Brief Summary
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Topotecan fights HIV and the JC virus (the virus that causes PML) in laboratory experiments.
Detailed Description
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Patients are randomized to be treated immediately with topotecan or to have treatment delayed for 8 weeks. The dosing schedule for patients receiving immediate or delayed treatment is topotecan as a continuous 21-day intravenous infusion every 28 days. All patients must have received optimal, stable antiretroviral therapy for 3 weeks prior to entry and preferably will continue that therapy during the study.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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Topotecan
Eligibility Criteria
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Inclusion Criteria
* Are HIV-positive.
* Have PML, including symptoms of PML.
* Are able to complete the study.
* Agree to have a catheter inserted in a vein.
* Have taken at least 3 weeks of a stable anti-HIV drug combination (unless they are unable to take anti-HIV drugs).
* Are at least 18 years old.
* Agree to use effective methods of birth control.
Exclusion Criteria
* Have a history of certain central nervous system (CNS) diseases.
* Have a history of certain psychiatric disorders, such as bipolar disorder or schizophrenia.
* Have syphilis that has not been treated.
* Have certain severe medical problems, including AIDS-related opportunistic infections (such as PCP) that require treatment.
* Have received chemotherapy in the past 30 days.
* Have ever received chemotherapy for PML.
* Are pregnant or breast-feeding.
* Are taking certain medications, including any other investigational drugs.
18 Years
ALL
No
Sponsors
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SmithKline Beecham
INDUSTRY
Locations
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Veteran's Administration Hosp / West LA
Los Angeles, California, United States
HIV Institute / Davies Med Ctr
San Francisco, California, United States
Univ of Miami
Miami, Florida, United States
Johns Hopkins Univ
Baltimore, Maryland, United States
Albany Med College / Div of HIV Medicine
Albany, New York, United States
Countries
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Other Identifiers
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Protocol 111
Identifier Type: -
Identifier Source: secondary_id
SK&F 104864-A
Identifier Type: -
Identifier Source: secondary_id
284A
Identifier Type: -
Identifier Source: org_study_id