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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00002395 |
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Date of registration:
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02/11/1999 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
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Scientific title:
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An Open, Comparative Phase II Study of Immediate Versus Delayed Treatment With Topotecan HCl Given as a Continuous 21-Day Infusion Every 28 Days to Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy |
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Date of first enrolment:
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June 1996 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00002395 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria
Patients may be eligible for this study if they:
- 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
Patients will not be eligible for this study if they:
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Leukoencephalopathy, Progressive Multifocal
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Intervention(s)
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Drug: Topotecan
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Secondary ID(s)
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Protocol 111
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284A
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SK&F 104864-A
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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