Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
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
3 other identifiers
interventional
54
1 country
5
Brief Summary
The purpose of this study is to see if it is safe and effective to give topotecan through a vein to treat HIV-infected patients with PML, an opportunistic (AIDS-related) infection caused by a virus that infects brain tissue and causes damage to the brain and the spinal cord. Topotecan fights HIV and the JC virus (the virus that causes PML) in laboratory experiments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
July 1, 2000
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Veteran's Administration Hosp / West LA
Los Angeles, California, 90073, United States
HIV Institute / Davies Med Ctr
San Francisco, California, 94114, United States
Univ of Miami
Miami, Florida, 33136, United States
Johns Hopkins Univ
Baltimore, Maryland, 21287, United States
Albany Med College / Div of HIV Medicine
Albany, New York, 12208, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2000-07